37,671 Device Development jobs in the United States
Senior Engineer, Device Development
01813
Vaxess Technologies
Posted today
Job Viewed
Job Description
Location: Woburn, MA
Vaxess is an NIH and venture-funded company developing a pipeline of next-generation therapeutics on the Microneedle Array Patch (MAP) platform. With only five minutes of wear-time on the skin, the self-applied MAP enables sustained delivery in the skin. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
Device development at Vaxess is cross-disciplinary, integrating mechanical engineering, biomedical engineering, chemical engineering, biomaterials, chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer with a proven track record in medical device development to support the design of our novel delivery system.
Responsibilities
- Work under the VP of Device Development to design the re-usable MAP delivery device. Focus for this role will be on product design, development, and design for high volume manufacturability.
- Support product development in support of pre-clinical and clinical studies.
- Work closely with the multidisciplinary Vaxess team and external consultants with specialties spanning Human Factors, Industrial Design, Packaging, Manufacturing, Engineering, Biocompatibility, Quality, and Regulatory.
- Lead the selection and management of outside vendors.
- Generate all required documents to support device related components of design control requirements (21 CFR 820, ISO 13485 ISO 14971) and regulatory requirements for combination products (21 CFR Part 4).
- Develop test methods, generate and maintain design specification, write protocols & reports, lead prototype generation, design verifications & validations, conduct FMEA’s, etc. in line with ISO 14971 Risk Management.
- Conduct activities within a quality management system following 21CFR820 Quality System Regulation .
- Mentor junior team members in the drug-device combination process.
Qualifications
- BS in Mechanical or Biomedical Engineering, with at least 7 years of direct experience leading the development of medical devices, ideally drug-device combination products .
- Understanding of material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is required.
- Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
- Collaborative problem solving, risk assessment, and risk management skills.
- Proven time management skills and ability to achieve goals within timelines.
- Demonstrated abilities to learn new skills and fields and creatively solve challenging technical problems.
- Entrepreneurial spirit and drive to positively impact global human health
Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment.
Vaxess aims to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.
If you’re interested in joining the Vaxess team, please submit your CV/resume to .
View Now
0
Device Development Engineer- Project Leadership
12061 Hampton Manor, New York
Regeneron Pharmaceuticals
Posted 11 days ago
Job Viewed
Job Description
Regeneron is seeking a Device Development Engineer to join our project lead team. The Device Development Engineer will drive the end-to-end development of a device combination product and/or platform delivery system, within a specific therapeutic area (Ophthalmic, Immunology/Inflammation, Cardiometabolic, etc.). They will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and multi-functional collaboration with internal and external partners, for the combination product device.
A typical day for a Device Development Engineer might include:
+ Leads multidisciplinary engineering project teams (Human Factors, V&V Engineering, Manufacturing Engineer, Quality Engineering) through the complete device design and development lifecycle of a combination product development within the Regeneron Pipeline.
+ Defines detailed product requirements and specifications with commercial, clinical, and other development/strategy collaborators.
+ Defines technical specifications and design requirements in collaboration with engineering teams (manufacturing, verification, packaging etc.)
+ Responsible for all user needs and requirements to be validated through design and development.
+ Develops, manages, and communicates development program plans, risks, timelines, and budgets to internal and external team members.
+ Integrate device development activities with Chemistry Manufacturing Controls (CMC) and Global development timing and goals.
+ Supports global internal manufacturing and external manufacturing teams around relevant design and process development information transfers.
+ Leads all aspects of product testing and quality assurance processes for the specific device development.
+ Ensures comprehensive and compliant Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21CFR Part 3 and 21 CFR 820.30).
+ Supports management in related clinical and commercial regulatory activities that is related to the device development (ie: IND/IMPD, BLA Submission, Clinical Pharmacy Manuals etc.)
+ Understands design inputs and outputs of multiple delivery systems and how it can impact end users.
+ Supports management and/or therapeutic area device project leads, in strategic product launch and go-to-market plans for the device development.
This role might be for you if you:
+ Understand relevant FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.
+ Have experience with design history file management (21 CFR 820.30), is a plus.
+ Possess strong project management and interpersonal skills and strong analytical and problem-solving capabilities.
+ Can balance business objectives with technical constraints.
+ Can work effectively across multiple functional teams.
+ Enjoy working in a fast-paced, multifaceted research and development environment.
+ Are willing and able to travel for partner meetings, audits, and project coordination activities.
To be considered for the Device Development Engineer you must have a B.S in Engineering. For various levels you must have the following:
+ Device Development Engineer: 2+ years of relevant experience
+ Sr. Device Development Engineer: 5+ years of relevant experience
+ Or equivalent combination of education & experience
Previous experience in product management/project management/ and/or project leadership related activities is preferred. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$74,200.00 - $141,800.00
A typical day for a Device Development Engineer might include:
+ Leads multidisciplinary engineering project teams (Human Factors, V&V Engineering, Manufacturing Engineer, Quality Engineering) through the complete device design and development lifecycle of a combination product development within the Regeneron Pipeline.
+ Defines detailed product requirements and specifications with commercial, clinical, and other development/strategy collaborators.
+ Defines technical specifications and design requirements in collaboration with engineering teams (manufacturing, verification, packaging etc.)
+ Responsible for all user needs and requirements to be validated through design and development.
+ Develops, manages, and communicates development program plans, risks, timelines, and budgets to internal and external team members.
+ Integrate device development activities with Chemistry Manufacturing Controls (CMC) and Global development timing and goals.
+ Supports global internal manufacturing and external manufacturing teams around relevant design and process development information transfers.
+ Leads all aspects of product testing and quality assurance processes for the specific device development.
+ Ensures comprehensive and compliant Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21CFR Part 3 and 21 CFR 820.30).
+ Supports management in related clinical and commercial regulatory activities that is related to the device development (ie: IND/IMPD, BLA Submission, Clinical Pharmacy Manuals etc.)
+ Understands design inputs and outputs of multiple delivery systems and how it can impact end users.
+ Supports management and/or therapeutic area device project leads, in strategic product launch and go-to-market plans for the device development.
This role might be for you if you:
+ Understand relevant FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.
+ Have experience with design history file management (21 CFR 820.30), is a plus.
+ Possess strong project management and interpersonal skills and strong analytical and problem-solving capabilities.
+ Can balance business objectives with technical constraints.
+ Can work effectively across multiple functional teams.
+ Enjoy working in a fast-paced, multifaceted research and development environment.
+ Are willing and able to travel for partner meetings, audits, and project coordination activities.
To be considered for the Device Development Engineer you must have a B.S in Engineering. For various levels you must have the following:
+ Device Development Engineer: 2+ years of relevant experience
+ Sr. Device Development Engineer: 5+ years of relevant experience
+ Or equivalent combination of education & experience
Previous experience in product management/project management/ and/or project leadership related activities is preferred. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$74,200.00 - $141,800.00
View Now
1
Senior Engineer, Device Development (Woburn)
01813
Vaxess Technologies
Posted 1 day ago
Job Viewed
Job Description
Location: Woburn, MA
Vaxess is an NIH and venture-funded company developing a pipeline of next-generation therapeutics on the Microneedle Array Patch (MAP) platform. With only five minutes of wear-time on the skin, the self-applied MAP enables sustained delivery in the skin. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
Device development at Vaxess is cross-disciplinary, integrating mechanical engineering, biomedical engineering, chemical engineering, biomaterials, chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer with a proven track record in medical device development to support the design of our novel delivery system.
Responsibilities
- Work under the VP of Device Development to design the re-usable MAP delivery device. Focus for this role will be on product design, development, and design for high volume manufacturability.
- Support product development in support of pre-clinical and clinical studies.
- Work closely with the multidisciplinary Vaxess team and external consultants with specialties spanning Human Factors, Industrial Design, Packaging, Manufacturing, Engineering, Biocompatibility, Quality, and Regulatory.
- Lead the selection and management of outside vendors.
- Generate all required documents to support device related components of design control requirements (21 CFR 820, ISO 13485 ISO 14971) and regulatory requirements for combination products (21 CFR Part 4).
- Develop test methods, generate and maintain design specification, write protocols & reports, lead prototype generation, design verifications & validations, conduct FMEAs, etc. in line with ISO 14971 Risk Management.
- Conduct activities within a quality management system following 21CFR820 Quality System Regulation .
- Mentor junior team members in the drug-device combination process.
Qualifications
- BS in Mechanical or Biomedical Engineering, with at least 7 years of direct experience leading the development of medical devices, ideally drug-device combination products .
- Understanding of material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is required.
- Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
- Collaborative problem solving, risk assessment, and risk management skills.
- Proven time management skills and ability to achieve goals within timelines.
- Demonstrated abilities to learn new skills and fields and creatively solve challenging technical problems.
- Entrepreneurial spirit and drive to positively impact global human health
Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment.
Vaxess aims to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.
If youre interested in joining the Vaxess team, please submit your CV/resume to .
View Now
2
Senior NPI Buyer-Medical Device Development
03054 Merrimack, New Hampshire
KMC Operations
Posted 8 days ago
Job Viewed
Job Description
The New Product Introduction (NPI) Buyer purchases a high volume and variety of materials, supplies, and services in support of Engineering and New Product Introduction. Evaluates bids, selects and recommends suppliers, and negotiates price, delivery, quality, and service. Follows-up on all awards until completion of order. Negotiates and settles with suppliers on rejections, losses, return of materials, over shipments, cancellations, and engineering changes.
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
Responsibilities:
- Sends out items for quote with input from Engineering Project Lead
- Generates purchase orders for NPI and does minimal negotiations to support order placement
- Can assist in locating replacements for obsolete components with engineering
- Assists in defining new processes with engineering to control drawing packages and components for prototyping and production processes
- Requires a sound knowledge of PLM and Central Catalog for discussions with Suppliers. Shares and may provide training to Supply Chain Buyer Planners, as needed
- Supports internal machining prototype personnel for making/buying decisions as well as ordering lower-level material required for in-house makes
- Processes Development Change Orders (DCO's) and work with suppliers to implement existing orders
- Utilizes pre-defined supplier selection as well as setting up new suppliers as dictated by new product types
- Able to work in a manual environment and maintain company policies without automated ERP tools
- Can expedite material through incoming inspection and internal suppliers using email requests
- Able to provide information both written and verbal to BU program managers for project status both for scheduling and financial purposes
- Cooperates with one's coworkers and helps project team meet goals
- Shares information and ideas with the team
- Meets all team deadlines and responsibilities
- Has taken the basic Code of Business Ethics training and has a basic understanding of its impact on the Buyer position
- Maintains database to provide necessary information regarding components, established designs, prices, drawing, and cost data to Engineering and Manufacturing
- Possesses some familiarity with regulatory requirements (RoHs, Reach, FAA, FDA, FAR/DFAR, ITAR/EAR)
- Interacts with multiple internal customers supplying price and delivery information as required
- Contacts Supplier-Requests RMA
- Checks for export license, if required
- Performs maintenance on Oracle supplier database, including updating supplier information and preserving documents needed for audit purposes (W-9, Denied Party, etc.)
- Supports Accounting with new supplier entries (check request, employees for Concur, etc.)
- Supports production buyer planner on joint prototype/Qual Units/LRIP programs
- Supports other ESA facilities on an "as needed" basis for joint projects
- Supports off site activities such as customer demos, and testing
- Performs other related duties, as required
Requirements:
- A Bachelor's Degree
- 5+ years' experience in Purchasing, Production Control, Inventory Control, Just in Time Production
- Must possess an understanding of Purchasing, Bills of Material, and other manufacturing modules
- Will have some knowledge of assigned commodities
- Must be able to generate spreadsheets, including creating formulas and formatting
- Requires basic skill level in Word and PowerPoint.
- American Production and Inventory Control Society (APICS) certification a plus
- Knowledge of Oracle system is a plus
- Some knowledge of Lean Manufacturing concepts is preferred
#LI-SW1Here Are Some of the Great Benefits We Offer:
- Most locations offer a 9/80 schedule, providing every other Friday off
- Competitive compensation & 401(k) program to plan for your future
- Robust medical, dental, vision, & disability coverage with qualified wellness discounts
- Basic Life Insurance and Additional Life & AD&D Insurances are available
- Flexible Vacation & PTO
- Paid Parental Leave
- Generous Employee Referral Program
- Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
- Voluntary Tricare Supplement available for military retirees
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
Apply Now
3
Senior NPI Buyer-Medical Device Development
03054 Merrimack, New Hampshire
Elbit America, Inc.
Posted 8 days ago
Job Viewed
Job Description
The New Product Introduction (NPI) Buyer purchases a high volume and variety of materials, supplies, and services in support of Engineering and New Product Introduction. Evaluates bids, selects and recommends suppliers, and negotiates price, delivery, quality, and service. Follows-up on all awards until completion of order. Negotiates and settles with suppliers on rejections, losses, return of materials, over shipments, cancellations, and engineering changes.
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
Responsibilities:
- Sends out items for quote with input from Engineering Project Lead
- Generates purchase orders for NPI and does minimal negotiations to support order placement
- Can assist in locating replacements for obsolete components with engineering
- Assists in defining new processes with engineering to control drawing packages and components for prototyping and production processes
- Requires a sound knowledge of PLM and Central Catalog for discussions with Suppliers. Shares and may provide training to Supply Chain Buyer Planners, as needed
- Supports internal machining prototype personnel for making/buying decisions as well as ordering lower-level material required for in-house makes
- Processes Development Change Orders (DCO's) and work with suppliers to implement existing orders
- Utilizes pre-defined supplier selection as well as setting up new suppliers as dictated by new product types
- Able to work in a manual environment and maintain company policies without automated ERP tools
- Can expedite material through incoming inspection and internal suppliers using email requests
- Able to provide information both written and verbal to BU program managers for project status both for scheduling and financial purposes
- Cooperates with one's coworkers and helps project team meet goals
- Shares information and ideas with the team
- Meets all team deadlines and responsibilities
- Has taken the basic Code of Business Ethics training and has a basic understanding of its impact on the Buyer position
- Maintains database to provide necessary information regarding components, established designs, prices, drawing, and cost data to Engineering and Manufacturing
- Possesses some familiarity with regulatory requirements (RoHs, Reach, FAA, FDA, FAR/DFAR, ITAR/EAR)
- Interacts with multiple internal customers supplying price and delivery information as required
- Contacts Supplier-Requests RMA
- Checks for export license, if required
- Performs maintenance on Oracle supplier database, including updating supplier information and preserving documents needed for audit purposes (W-9, Denied Party, etc.)
- Supports Accounting with new supplier entries (check request, employees for Concur, etc.)
- Supports production buyer planner on joint prototype/Qual Units/LRIP programs
- Supports other ESA facilities on an "as needed" basis for joint projects
- Supports off site activities such as customer demos, and testing
- Performs other related duties, as required
Requirements:
- A Bachelor's Degree
- 5+ years' experience in Purchasing, Production Control, Inventory Control, Just in Time Production
- Must possess an understanding of Purchasing, Bills of Material, and other manufacturing modules
- Will have some knowledge of assigned commodities
- Must be able to generate spreadsheets, including creating formulas and formatting
- Requires basic skill level in Word and PowerPoint.
- American Production and Inventory Control Society (APICS) certification a plus
- Knowledge of Oracle system is a plus
- Some knowledge of Lean Manufacturing concepts is preferred
#LI-SW1Here Are Some of the Great Benefits We Offer:
- Most locations offer a 9/80 schedule, providing every other Friday off
- Competitive compensation & 401(k) program to plan for your future
- Robust medical, dental, vision, & disability coverage with qualified wellness discounts
- Basic Life Insurance and Additional Life & AD&D Insurances are available
- Flexible Vacation & PTO
- Paid Parental Leave
- Generous Employee Referral Program
- Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
- Voluntary Tricare Supplement available for military retirees
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
Apply Now
4
Dir Business Development-Medical Device Development
03054 Merrimack, New Hampshire
Elbit America, Inc.
Posted 13 days ago
Job Viewed
Job Description
The Director, Business Development will lead the formulation and implementation of business development plans for KMC Systems.
Qualifications:
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
Principal Responsibilities :
- Assure effective communication with pertinent customer community, current and prospective, for the purpose of assessing customer requirements, apprising the customer community of KMC capabilities relative to their requirements, and assisting customers in the definition of their requirements
- Maintain up‑to‑date knowledge of current, mid‑term and long‑term customer programs pertinent to assigned product(s) or areas. Such knowledge shall include, but not limited to:
- Technical needs of OEM Customers
- Thorough understanding of IVD and Life Sciences market trends at key OEMs
- Competitive product developments
- Funding status of programs and R & D at major OEMs
- Keep the Vice President Bus Dev informed on the current status of pertinent activities and developments
- Assign resources/personnel to investigate marketing opportunities in assigned areas
- Identify and evaluate potential opportunities within an assigned market segment
- Develop and implement marketing strategies for assigned target market segments
- Propose marketing strategies and contribute to long range plans based on knowledge of the marketing analysis of potential market needs and the company's capabilities, predicted technology trends, and information on competitive efforts
- Identify and recommend potential programs for proposal efforts appropriate to goals and capabilities
- Lead proposal preparation efforts from the development of win strategies to the formulation of bid/no bid recommendations
- Assure proposal plan best addresses customer needs
- Play a key role in formulating the most competitive position for winning targeted programs
- Present a step‑by‑step plan to insure a competitive/winning bid
- Coordinate efforts between customers and Elbit Systems of America- Merrimack Marketing, Engineering, Contracts and other key personnel as required for successful pursuit of new business
- Maintain communication with company engineers for an up‑to‑date knowledge of company products and technical capabilities
- Represent the company in trade shows and related efforts.
- Develop and manage presentations given to customer personnel in support of sales efforts for assigned area
Qualifications:
- Bachelor's degree in engineering or sciences with 10+ years' of directly related experience
- Prior experience in a technical role is a plus
- Successful track record in Business Development, Sales/Marketing
- Experience within engineering services, automation or FDA-regulated markets
#LI-SW1Here Are Some of the Great Benefits We Offer:
- Most locations offer a 9/80 schedule, providing every other Friday off
- Competitive compensation & 401(k) program to plan for your future
- Robust medical, dental, vision, & disability coverage with qualified wellness discounts
- Basic Life Insurance and Additional Life & AD&D Insurances are available
- Flexible Vacation & PTO
- Paid Parental Leave
- Generous Employee Referral Program
- Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
- Voluntary Tricare Supplement available for military retirees
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
Apply Now
5
Associate Director, Device Clinical Development
02421
Takeda Pharmaceuticals
Posted 1 day ago
Job Viewed
Job Description
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
**About the Role:**
The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device Development (DPDD) group provides strategic clinical leadership for global device and combination product development programs. This pivotal role involves orchestrating device clinical and risk management strategies, establishing comprehensive product training frameworks, and ensuring rigorous adherence to design control principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards.
**Core Responsibilities:**
**Device Clinical Strategy & Risk Management:**
+ Develop Device Clinical Development Strategy for Combination Products and Medical Devices
+ Develop comprehensive risk management strategies for devices and combination products including patient harm assessment in Hazard Analysis
+ Support translation of clinical and user needs into technical requirements
+ Coordinate risk mitigation activities across clinical, regulatory, quality, and engineering functions
+ Perform safety reviews on device and combination products from clinical trials and from the field
**Training Development:**
+ Design evidence-based product use training programs for patients, healthcare professionals, and clinical trial staff
+ Develop innovative instructional methodologies aligned with developmentally tailored learning principles
+ Establish metrics to evaluate training effectiveness and implement continuous improvement
**Clinical Quality Assurance & Compliance:**
+ Implement quality management systems for clinical activities related to device development
+ Develop and maintain clinical SOPs and clinical trial related device documentation
+ Support quality audits and implement corrective and preventive actions (CAPAs)
**Clinical Trial Support:**
+ Develop device-specific training materials and review protocols for clinical trials
+ Implement train-the-trainer programs for clinical research sites
+ Provide real-time clinical guidance on device-related aspects during trials
**Design Control Adherence:**
+ Ensure clinical input is incorporated throughout the design control processes
+ Review and approve user requirements, design specifications, and verification/validation plans
+ Maintain traceability between clinical needs and technical specifications
**Human Factors & Usability:**
+ Support use workflow development and usability engineering processes
+ Support formative and summative human factors study training
**Regulatory Engagement:**
+ Support audits from internal teams and Health Authorities related to device clinical development
+ Prepare clinical sections for regulatory submissions (IDE, 510(k), PMA, IND, NDA, BLA)
+ Represent clinical perspectives in regulatory meetings and correspondence
**Vendor Management:**
+ Provide subject matter expertise and mentorship to vendors performing clinical functions
+ Establish vendor oversight frameworks and performance metrics
+ Conduct vendor qualification, selection, and performance evaluation
**Cross-functional Collaboration:**
+ Facilitate seamless integration between clinical functions and device development teams
+ Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs, quality, and commercial functions
+ Coordinate interdepartmental initiatives to optimize device clinical development timelines
**Process Innovation:**
+ Lead initiatives to improve efficiency of clinical development processes
+ Implement data-driven approaches to optimize clinical activities
+ Develop innovative solutions to streamline device clinical development
**Team Leadership & Development:**
+ Promote a culture of scientific excellence, adherence to regulatory and quality standards, and patient-focused innovation.
+ Lead, mentor, and develop organization on device clinical development best practices, strategies, and trends
**Required Qualifications:**
+ An advanced degree in medical, clinical, healthcare science, or a related field:
**Doctorate degree with 7+ years of experience, OR**
**Master's degree with 13+ years of experience, OR**
**Bachelor's degree with 15+ years of experience**
+ Minimum 5 years of combination product, medical device, or pharmaceutical industry experience
+ Experience with both medical devices, drug-device combination products, digital health technologies across multiple therapeutic areas
+ Experience with device design control processes and risk management methodologies
+ Thorough understanding of FDA, EMA, and international regulations for medical devices and combination products
+ Proven ability to thrive in a fast-paced environment supporting multiple development programs
**Preferred Qualifications:**
+ A Health Care Provider (HCP) that is practicing part-time (no more than 5 days per month) is strongly preferred
+ Advanced program management skills
+ Strong background in clinical research methodology
+ Exceptional stakeholder management and conflict resolution capabilities
This role offers an exceptional opportunity to drive innovation at the intersection of medical devices and pharmaceutical development, with significant impact on patient care and treatment outcomes.
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Lexington, MA
**U.S. Base Salary Range:**
$153,600.00 - $241,340.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Lexington, MA
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Job Description**
**About the Role:**
The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device Development (DPDD) group provides strategic clinical leadership for global device and combination product development programs. This pivotal role involves orchestrating device clinical and risk management strategies, establishing comprehensive product training frameworks, and ensuring rigorous adherence to design control principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards.
**Core Responsibilities:**
**Device Clinical Strategy & Risk Management:**
+ Develop Device Clinical Development Strategy for Combination Products and Medical Devices
+ Develop comprehensive risk management strategies for devices and combination products including patient harm assessment in Hazard Analysis
+ Support translation of clinical and user needs into technical requirements
+ Coordinate risk mitigation activities across clinical, regulatory, quality, and engineering functions
+ Perform safety reviews on device and combination products from clinical trials and from the field
**Training Development:**
+ Design evidence-based product use training programs for patients, healthcare professionals, and clinical trial staff
+ Develop innovative instructional methodologies aligned with developmentally tailored learning principles
+ Establish metrics to evaluate training effectiveness and implement continuous improvement
**Clinical Quality Assurance & Compliance:**
+ Implement quality management systems for clinical activities related to device development
+ Develop and maintain clinical SOPs and clinical trial related device documentation
+ Support quality audits and implement corrective and preventive actions (CAPAs)
**Clinical Trial Support:**
+ Develop device-specific training materials and review protocols for clinical trials
+ Implement train-the-trainer programs for clinical research sites
+ Provide real-time clinical guidance on device-related aspects during trials
**Design Control Adherence:**
+ Ensure clinical input is incorporated throughout the design control processes
+ Review and approve user requirements, design specifications, and verification/validation plans
+ Maintain traceability between clinical needs and technical specifications
**Human Factors & Usability:**
+ Support use workflow development and usability engineering processes
+ Support formative and summative human factors study training
**Regulatory Engagement:**
+ Support audits from internal teams and Health Authorities related to device clinical development
+ Prepare clinical sections for regulatory submissions (IDE, 510(k), PMA, IND, NDA, BLA)
+ Represent clinical perspectives in regulatory meetings and correspondence
**Vendor Management:**
+ Provide subject matter expertise and mentorship to vendors performing clinical functions
+ Establish vendor oversight frameworks and performance metrics
+ Conduct vendor qualification, selection, and performance evaluation
**Cross-functional Collaboration:**
+ Facilitate seamless integration between clinical functions and device development teams
+ Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs, quality, and commercial functions
+ Coordinate interdepartmental initiatives to optimize device clinical development timelines
**Process Innovation:**
+ Lead initiatives to improve efficiency of clinical development processes
+ Implement data-driven approaches to optimize clinical activities
+ Develop innovative solutions to streamline device clinical development
**Team Leadership & Development:**
+ Promote a culture of scientific excellence, adherence to regulatory and quality standards, and patient-focused innovation.
+ Lead, mentor, and develop organization on device clinical development best practices, strategies, and trends
**Required Qualifications:**
+ An advanced degree in medical, clinical, healthcare science, or a related field:
**Doctorate degree with 7+ years of experience, OR**
**Master's degree with 13+ years of experience, OR**
**Bachelor's degree with 15+ years of experience**
+ Minimum 5 years of combination product, medical device, or pharmaceutical industry experience
+ Experience with both medical devices, drug-device combination products, digital health technologies across multiple therapeutic areas
+ Experience with device design control processes and risk management methodologies
+ Thorough understanding of FDA, EMA, and international regulations for medical devices and combination products
+ Proven ability to thrive in a fast-paced environment supporting multiple development programs
**Preferred Qualifications:**
+ A Health Care Provider (HCP) that is practicing part-time (no more than 5 days per month) is strongly preferred
+ Advanced program management skills
+ Strong background in clinical research methodology
+ Exceptional stakeholder management and conflict resolution capabilities
This role offers an exceptional opportunity to drive innovation at the intersection of medical devices and pharmaceutical development, with significant impact on patient care and treatment outcomes.
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Lexington, MA
**U.S. Base Salary Range:**
$153,600.00 - $241,340.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Lexington, MA
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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6
R&d Product Development Engineer
Remote
$45 - $55 per hour
Compass Realty Inc
Posted 27 days ago
Job Viewed
Job Description
We are seeking an innovative and detail-oriented R&D Product Development Engineer to design, develop, and improve new products from concept to production. The role involves conducting research, prototyping, testing, and collaborating with cross-functional teams to deliver high-quality, market-ready solutions.
Key Responsibilities
• Lead research, design, and development of new products, components, and systems.
• Analyze customer needs, market trends, and competitor products to guide design decisions.
• Create and test prototypes using CAD software, simulation tools, and lab equipment.
• Conduct product testing, validation, and verification to ensure compliance with quality, safety, and regulatory standards.
• Collaborate with manufacturing, quality, marketing, and supply chain teams to transition designs into production.
• Prepare technical reports, documentation, and specifications for internal and external stakeholders.
• Support continuous improvement of existing products by identifying design enhancements or cost reductions.
• Stay current with emerging technologies, materials, and industry best practices.
• Manage multiple projects simultaneously, meeting deadlines and budget requirements.
Qualifications
• Bachelor’s degree in Mechanical, Electrical, Materials, Chemical, or related Engineering field (Master’s preferred for some roles).
• Proven experience in R&D, product design, or product development engineering.
• Strong knowledge of CAD software (SolidWorks, AutoCAD, CATIA, or similar).
• Familiarity with prototyping, testing, and validation techniques.
• Understanding of manufacturing processes, materials science, and design for manufacturability (DFM).
• Strong problem-solving, analytical, and creative design skills.
• Excellent communication and teamwork abilities.
• Knowledge of regulatory standards and quality systems (ISO, FDA, CE, etc.) is an advantage.
Work Environment
• Collaboration with R&D, design, production, and marketing teams.
• Hands-on prototyping and lab testing.
• Fast-paced environment with emphasis on innovation and continuous improvement.
Career Path
• Progression to roles such as Senior Product Development Engineer , R&D Manager , Innovation Manager , or Director of Product Development .
Company Details
Compass Realty Inc offers you the best real estate service for buyers and sellers in the Capital District. Compass Realtyis a local, independent firm dealing in Residential and Commercial real estate within New York’s Capital Region.Compass Realty represents sellers with and buyers. Compass Realty specializes in assisting people like you buy and sell your home.Compass Realty Inc. is dedicated to providing you more than just a house in your price range, your dream home is out there, and we want to help you discover how much home you can really buy in the current market.
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7
Product Development Coordinator
92632 Fullerton, California
Wine Country Gift Baskets
Posted today
Job Viewed
Job Description
Please note: This is a full-time, on-site position based in Fullerton.
Overview of Job Description:
The Product Development Project Coordinator is responsible for assisting and supporting all phases of Food, Wine and Gift packaging development from Concept to Production. The coordinator assists the Project manager, tracking timelines and milestones for multiple items in various stages of development throughout the year. This position interfaces with several departments and vendors to obtain product information to meet timelines.
Primary Tasks and Responsibilities:
- Assist with maintaining all Product Development schedules and timelines.
- Initiate, maintain and update all Product Development Files.
- Assist with Managing multiple projects at different stages of the development process.
- Prepare Nutritional and technical file Inserts using Adobe Illustrator.
- Create new component sheets for all Product Development packages.
- Assist with proofing of all artwork, legal and FDA information on packaging, labels and informational sheets.
- Review all vendors print proofs for mass production.
- Create contents labels for towers/gifts (Wholesale & WC) using Adobe Illustrator and Bartender.
- ·Assist with maintaining Nutritional & Kosher Libraries and Product files with updates.
- Manage and support Label Group communications and requests to meet all Production timelines.
- Manage Wine Label development process and prepare all documents for proofing review and annual approvals.
Secondary Tasks and Responsibilities
- Work closely with the Purchasing team to obtain all Nutritional information: NFPs, ingredients and allergens/declarations.
- Assist with proofing all Export labels and documentation.
- Provide administrative support to the Project Manager as needed.
- Assist with gathering all regulatory documents and cataloging.
- Follow up with all teams on outstanding deliverables to meet timelines.
- Assist with other tasks as assigned by management.
Knowledge, Skills and Abilities:
- Possess strong written and verbal communication skills.
- Possess a Basic understanding of Project Coordination and Management
- Ability to understand product specifications and measurements.
- Ability to Type 40 WPM or More
- Highly Proficient with: MS-Office: Excel, Outlook, PowerPoint
- Ability to create and maintain complex/detailed spreadsheets.
- Knowledge of Adobe Illustrator (preferred, but will train)
- Ability to multi-task in a fast-paced environment.
- Possess a clear sense of ownership and accountability in your responsibilities.
- Possess attention to detail, problem-solving and accuracy.
- Excellent time management skills.
- Ability to prioritize and manage daily workload.
- Work overtime as needed voluntary and mandatory.
Education:
- AA Degree or equivalent work experience
- Project Coordination and/or Management courses
Experience:
- 2+ years in a Project Coordinator position
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