35 Device Development jobs in the United States

KMC Systems, an Elbit Systems of America Company, offers an ecosystem of engineering and innovation to develop the most advanced clinical and operational solutions for leading medical device customers across a diverse range of market segments. KMC was established in Merrimack, NH, in 1980, conveying almost half a century of innovation, R&D of next-generation instruments/medical devices, and the agility to evolve to meet changing market dynamics. This has kept KMC at the forefront of technological advancements and as the premier choice for leading global medical device and healthcare companies. KMC is a full-suite provider with services in: Product Ideation, Engineering Design, Product Lifecycle Management, Manufacturing, and Sustaining Engineering.

We are looking for extraordinary people to join KMC. For more information, please visit KMC Systems.

Job Summary:

KMC Systems is expanding its product and service offerings to offer greater sustained value to our customers. To enable our value creation strategy, we are looking for a Product Manager responsible for developing our new offerings and drive their market penetration. The incumbent is expected to build clear understanding of market needs & trends, upcoming requirements and builds a stream of solutions to best position our current and future portfolio to deliver on revenue and margin expectations. This role will build upstream market understanding and align the global market penetration strategy and progress them through new product development stages to product launch. This individual is expected to build relationships with key opinion leaders within our current and potential strategic accounts, professional organizations and relevant internal functions, to enrich and strengthen the overall innovation agenda throughout the strategic plan horizon.

Responsibilities

• Champion development of end market growth strategies based on upstream fact-based analysis of market trends; competitive applications portfolios; technology advancements; and customer needs assessment and regulatory requirements

• Leads development and prioritization of focus segment applications that enable our solutions to be differentiated and value-add to our customers

• Architect technical support strategy to reflect market focused initiatives including establishing and managing collaborator agreements/relationships on global basis to drive market penetration

• Lead the development of best practices to develop effective value propositions and sales tools that are practical to use and aligned to segmentation and requirements

• Drive deployment of commercial sales tools and training to drive sales effectiveness at positioning our solutions

• Meets business and end market KPIs, such as revenue, margin expansion market penetration and share gain.

• Support the development of strategic planning initiatives, M&A due diligence and other new growth initiatives

Education, Experience & License or Certification

• Bachelor's degree in engineering or sciences with 5+ years' experience
• Successful track record in various roles within Sales, Marketing, Product Management or R&D related to software and/or electronics-based products or engineering services within FDA regulated markets
• Experience in customer and market segmentation, creating portfolio roadmaps, robust business cases, and commercialization of solutions

Skills and Abilities

• Ability to develop customer needs into solutions driving business growth
• Ability to travel up to 20%

#LI-SW1

Here Are Some of the Great Benefits We Offer:

• Most locations offer a 9/80 schedule providing every other Friday off
• Competitive compensation & 401k 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 a contract for employment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Elbit America is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

Join to apply for the Senior Director, Device Development role at Alexion Pharmaceuticals, Inc.

Join to apply for the Senior Director, Device Development role at Alexion Pharmaceuticals, Inc.

Get AI-powered advice on this job and more exclusive features.

At AstraZeneca, we win through the science, it is at the heart of our every success. Every decision is rooted in the limitless possibilities of what science can do. We push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. It gives us a reason to come to work every day. It reminds us why we exist as a company. It helps us deliver benefits to patients and build new value for shareholders. It also sets the context for our employees activities and the roles of our teams, partners, and other collaborators. AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Introduction To Role

Are you ready to lead the charge in device development for Alexion products? As the Senior Director, Device Development, you'll be at the forefront of continuous product improvement within the Global Product Development function. This pivotal role involves leading device development activities and being responsible for Device/Combination Product Project development to support the Alexion Portfolio. You'll lead projects, support documentation, and drive related activities that make a difference!

Accountabilities

• Lead Device/Combination product projects to support molecules developed by Alexion with cross-functional teams.
• Drive activities related to the project, including design control activities, design verification, and modernization to support coordinated design control activities from clinical development through registration and commercial support.
• Perform deep reviews of the projects with engineers to ensure technical and timing robustness.
• Support Due Diligence for new acquisitions or new device technologies.
• Ensure all designs function as required and align with the Companys quality assurance requirements as well as applicable regulatory requirements.
  
  

Essential Skills/Experience

• Bachelors or Masters in Engineering (Mechanical, Electrical Engineering, Biomedical or Chemical), plus 10-15 years of experience in medical device development.
• Minimum of 8 years of direct multi-functional program management experience in the development and commercialization of device branded products.
• Mandatory experience of commercialization of mechanical or electro-mechanical injection systems or similar drug delivery presentation.
• Mandatory working experience in phase-based design control activities with coordinated risk management work and human factors/usability engineering studies, from research through registration, launch, and life cycle management.
• Demonstrated success leading multi-site, global or enterprise-wide programs in the biotech/pharmaceutical industry.
• Experience in interacting with R&D to understand early Device/Combination product needs and develop roadmaps.
• Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base.
• Effective communication, collaboration, and team-building skills; ability to connect with all levels of the organization. Proficient in authoring internal reports, project summaries, and internal/external presentations.
• Deep knowledge of the performance, safety, and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g., ISO 11608 series, ISO 14971, IEC 60601 series, IEC 62304, FDA QSR 21 CFR Part 4 and 820 / ISO13485 quality system requirements, and related FDA guidance).
  

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $207,924 to $11,886. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program (401(k) plan); paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At AstraZeneca, you'll find an environment where diversity is celebrated and innovation thrives. Our patient-driven culture is energizing and kind, fostering connections that lead to groundbreaking ideas impacting patients' lives. We value inclusion and different perspectives, ensuring that life-changing ideas can emerge from anywhere. Our commitment to kindness is as strong as our ambition to succeed for those in need. We take pride in giving back to our communities.

Ready to make a difference? Apply now and join us on this exciting journey!

Date Posted

04-Aug-2025

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Seniority level

• Seniority level Director

Employment type

• Employment type Full-time

Job function

• Job function Other

Referrals increase your chances of interviewing at Alexion Pharmaceuticals, Inc. by 2x

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#J-18808-Ljbffr

At AstraZeneca, we win through the science, it is at the heart of our every success. Every decision is rooted in the limitless possibilities of what science can do. We push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. It gives us a reason to come to work every day. It reminds us why we exist as a company. It helps us deliver benefits to patients and build new value for shareholders. It also sets the context for our employees activities and the roles of our teams, partners, and other collaborators. AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Introduction to role:

Are you ready to lead the charge in device development for Alexion products? As the Senior Director, Device Development, you'll be at the forefront of continuous product improvement within the Global Product Development function. This pivotal role involves leading device development activities and being responsible for Device/Combination Product Project development to support the Alexion Portfolio. You'll lead projects, support documentation, and drive related activities that make a difference!

Accountabilities:

• Lead Device/Combination product projects to support molecules developed by Alexion with cross-functional teams.

• Drive activities related to the project, including design control activities, design verification, and modernization to support coordinated design control activities from clinical development through registration and commercial support.

• Perform deep reviews of the projects with engineers to ensure technical and timing robustness.

• Support Due Diligence for new acquisitions or new device technologies.

• Ensure all designs function as required and align with the Companys quality assurance requirements as well as applicable regulatory requirements.

Essential Skills/Experience:

• Bachelors or Masters in Engineering (Mechanical, Electrical Engineering, Biomedical or Chemical), plus 10-15 years of experience in medical device development.

• Minimum of 8 years of direct multi-functional program management experience in the development and commercialization of device branded products.

• Mandatory experience of commercialization of mechanical or electro-mechanical injection systems or similar drug delivery presentation.

• Mandatory working experience in phase-based design control activities with coordinated risk management work and human factors/usability engineering studies, from research through registration, launch, and life cycle management.

  • Demonstrated success leading multi-site, global or enterprise-wide programs in the biotech/pharmaceutical industry.

  • Experience in interacting with R&D to understand early Device/Combination product needs and develop roadmaps.

  • Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base.

  • Effective communication, collaboration, and team-building skills; ability to connect with all levels of the organization. Proficient in authoring internal reports, project summaries, and internal/external presentations.

  • Deep knowledge of the performance, safety, and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g., ISO 11608 series, ISO 14971, IEC 60601 series, IEC 62304, FDA QSR 21 CFR Part 4 and 820 / ISO13485 quality system requirements, and related FDA guidance).

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $207,924 to $311,886. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program (401(k) plan); paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At AstraZeneca, you'll find an environment where diversity is celebrated and innovation thrives. Our patient-driven culture is energizing and kind, fostering connections that lead to groundbreaking ideas impacting patients' lives. We value inclusion and different perspectives, ensuring that life-changing ideas can emerge from anywhere. Our commitment to kindness is as strong as our ambition to succeed for those in need. We take pride in giving back to our communities.

Ready to make a difference? Apply now and join us on this exciting journey!

Date Posted

04-Aug-2025

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

#J-18808-Ljbffr

Regeneron is currently looking for a Principal/Staff Device Development Engineer to join our project lead team. This is a non-lab based position. They will drive the end-to-end platform development of a device combination products and/or innovative platform drug delivery systems, that will eventually be utilized by our patients on the market. In this role you will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and cross-functional collaboration with internal and external stakeholders, for the internally design platform delivery systems.
A typical day for a Principal/Staff Device Development Engineer might include:
+ Leads multidisciplinary engineering project teams (Design Engineering, Human Factors, V&V Engineering, Manufacturing Engineer, Quality Engineering) through the complete device design and development lifecycle of an off the shelf, or an internally designed platform medical device delivery system.
+ Defines detailed product requirements and specifications with commercial, clinical, and other development/strategy partners.
+ Targeted to have direct reports or mentees within the device project leadership team/organization, to support multiple platform device developments.
+ Responsible for all user needs and requirements to be validated through design and development
+ Develops, leads, and communicates development program plans, risks, timelines, and budgets to internal and external collaborators.
+ Manages relationships with all CDMOs and manufacturers related to device component manufacturing.
+ Support the integration of developed device platforms with the pairings of upcoming drug products within the Regeneron pipeline, based on need and scope.
+ Supports internal and external manufacturing teams around relevant design and process development information transfers (understands design for manufacturing principles, is a plus).
+ Ensures comprehensive and compliant Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21 CFR 820.30)
+ Supports and aligns all clinical and commercial regulatory activities related to device development, including (not limited to): 510K Submission, Biologics License Application (BLA) Submissions, Information Requests (IRs)
+ Defines technical specifications and design requirements in collaboration with engineering teams (product design, manufacturing, verification, packaging etc.)
+ Manages product development timelines and critical milestones with internal design teams and external partners/CDMOs.
+ Leads all aspects of product testing and quality assurance processes for the specific device development.
+ Drives strategic product launch and go-to-market plans with new technologies management and combination product leadership teams.
+ Understands crucial design inputs and outputs of different types of delivery systems (different delivery sites) and how it can impact end users.
+ Builds comprehensive product roadmaps and helps supports strategic plans to ensure a clear, compelling product vision is articulated to senior leadership.
+ Crafts and analyzes cases to support value propositions of new delivery systems being developed for the Regeneron Pipeline.
This role might be for you if you:
+ Successfully managing sophisticated, multi-disciplinary development projects.
+ Understand regulatory compliance and clinical trial processes (thorough understanding of relevant FDA regulations, particularly 21 CFR 820.30 and 21 CFR Part 3, is a plus).
+ Understand design of manufacturing principles and component manufacturing (ie: plastic molding), is a plus.
+ Possess strong project management and interpersonal skills, analytical and problem-solving capabilities.
+ Have experience with regulatory submissions and clinical protocol development.
+ Can balance business objectives with technical constraints.
+ Enjoy working in a fast-paced, multifaceted research and development environment.
+ Are willing/able to travel occasionally for collaborator meetings, audits, and project coordination.
To be considered for the Principal/Staff Device Development Engineer you must have a B.S in Engineering; biomedical engineering or mechanical engineering is preferred. You must be willing and able to work Monday-Friday, 8am-4:30pm. For various levels you must have the following:
+ Principal Device Development Engineer: 8+ years of relevant experience
+ Staff Device Development Engineer: 10+ years of relevant experience
+ Or equivalent combination of education and experience
Previous experience in combination product/medical device development or similar area is required. Experience with design history file management (21CFR 820.30), is preferred. Level is determined based on qualifications relevant to the role.
#LI-MB1
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)**
$101,800.00 - $194,500.00

The Director, Business Development will lead the formulation and implementation of business development plans for KMC Systems.

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 & 401k 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 a contract for employment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

KMC Systems, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

About KMC

KMC Systems is a leading design, development and manufacturer of MedTech devices and instrumentation for OEM's in the areas of diagnostic, therapeutic, and biomedical products. With more than 40 years of experience, KMC Systems is an ISO 13485 certified and FDA registered firm with expertise in all aspects of medical product development, verification, design for and transition to production. Additional capabilities include flexible turnkey manufacturing, depot repair and full compliance with FDA QSR regulations and GMP practices.

Overview:

We are seeking a seasoned Director of Program Management to lead our global Program Management Office. The ideal candidate brings deep experience delivering large-scale, complex automation systems that integrate hardware and software, ideally in regulated or high-performance environments such as MedTech, diagnostics, or industrial automation. You will be responsible for building and driving execution discipline across all product development programs, ensuring alignment with strategic goals, optimal resource utilization, and delivery of quality outcomes on time and on budget. You will play a pivotal role in driving engineering execution from early development through pilot build and ensuring a smooth and effective transfer to manufacturing.

Key Responsibilities:

• Lead and scale the PMO to support a portfolio of complex, cross-functional programs involving mechanical, electrical, software, and systems integration.
• Define and continuously improve program governance, processes, and tools to ensure consistent execution excellence.
• Drive end-to-end program execution, from concept through design, pilot build, and transfer to manufacturing.
• Own and drive engineering schedules and resource plans, ensuring milestones are met across product and system-level deliverables.
• Manage a global team of program managers and cross-functional contributors, coordinating work across multiple time zones and engineering centers.
• Act as a strategic thought partner to R&D, Engineering, Operations, and Commercial teams.
• Implement robust metrics and KPIs to monitor program health, highlight variances, and enable proactive decision-making.
• Serve as an escalation point for program risks and challenges; develop recovery plans and align stakeholders.
• Lead executive program reviews and provide clear status updates and recommendations to senior leadership.
• Foster a culture of accountability, collaboration, and continuous improvement

Qualifications and Requirements:

• 10+ years of experience in program or product management roles within complex, multidisciplinary product development environments.
• Proven track record leading large-scale automation programs involving both hardware and software integration.
• Demonstrated experience driving engineering execution, pilot builds, and transfer to manufacturing.
• Experience managing teams and resources globally, including offshore or outsourced engineering teams.
• Deep understanding of product development lifecycles, from concept through design transfer and launch.
• Strong financial acumen with experience managing program budgets and resource planning.
• Expertise in program tools (e.g., Smartsheet, MS Project, Jira, Confluence) and project portfolio management frameworks.
• Background in medical devices, diagnostics, or other regulated industries.
• Bachelors degree in relevant discipline
• Program Management Professional certification is a plus.
• Experience standing up or transforming a PMO function in a scaling organization
• Excellent communication, leadership, and stakeholder management skills

#LI-SW1Here Are Some of the Great Benefits We Offer:

• Most locations offer a 9/80 schedule providing every other Friday off
• Competitive compensation & 401k 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 a contract for employment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Elbit America is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

Position:

Embedded Engineer- Virtio Device Development (eInfochips Inc.)

Job Description:

What candidate will Be Doing:

• Take high-level technical requirements and translate them into well-architected solutions, executing with minimal oversight.

• Support both embedded/edge virtualization and cloud-based virtualized environments, ensuring scalability, performance, and reliability.

• Develop and extend Virtio devices including virtio-audio, virtio-gpu, virtio-vsock, and virtio-net, with a deep understanding of Virtio specification internals.

• Actively participate in R&D discussions and collaborate with standards bodies to shape the evolution of virtualization technologies.

• Integrate virtualization solutions into cloud/container ecosystems leveraging AWS, Docker, Kubernetes, and CI/CD workflows.

• Work cross-functionally with hardware, firmware, and software teams to troubleshoot and optimize virtualization frameworks.

What we are looking for:

• VirtIO (device development & extensions).

• Overall 8+ years of experience in Embedded side.

• OASIS Virtio standards & Linux Kernel Virtio subsystems.

• AWS, Docker, Kubernetes, CI/CD workflows for virtualized environments.

• Embedded C, C++, Assembly.

Work Arrangement Fully Onsite: Must be able to travel to an Arrow Client office location as requested by Arrow Client leadership.

Location: Completed Onsite at Peachtree City, GA .

What's In It for You:

At Arrow, we recognize that financial rewards and great benefits are important aspects of an ideal job. That's why we offer competitive financial compensation, including various compensation plans and a solid benefits package.

• Medical, Dental, Vision Insurance

• 401k, With Matching Contributions

• Short-Term/Long-Term Disability Insurance

• Health Savings Account (HSA)/Health Reimbursement Account (HRA) Options

• Paid Time Off (including sick, holiday, vacation, etc.)

• Tuition Reimbursement

• Growth Opportunities

• And more!

About eInfochips: eInfochips , an Arrow company (Fortune #133), is a leading global provider of product engineering and semiconductor design services. A rich history of over two decades, with over 500+ products developed and 40M deployments in 140 countries, eInfochips continues to fuel technological innovations in multiple verticals. eInfochips has strategic technology partnerships with Qualcomm, NVIDIA, NXP, Analog Devices, Texas Instruments, Amazon, Microsoft and Google to name a few. Along with Arrow's $38B in revenues, 22,000 employees, and 345 locations serving over 80 countries, eInfochips is primed to accelerate connected products innovation for 150,000+ global clients. eInfochips acts as a catalyst to Arrow's Sensor-to-Sunset initiative and offers complete edge-to-cloud capabilities for its clients. Please visit for our portfolio of product engineering services across various industries & verticals.

EEO Statement: Arrow is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, gender, age, sexual orientation, gender identity, national origin, veteran or disability status. (Arrow EEO/AAP policy)

Location:

US-GA-Peachtree City-Georgia (Panasonic Auto)

Time Type:

Full time

Job Category:

Engineering Services

EEO Statement:

Arrow is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, gender, age, sexual orientation, gender identity, national origin, veteran or disability status. (Arrow EEO/AAP policy) (

We anticipate this requisition will be open for a minimum of five days, though it may be open for a longer period of time. We encourage your prompt application.

Arrow Electronics, Inc.'s policy is to provide equal employment opportunities to all qualified employees and applicants without regard to race, color, religion, age, sex, marital status, gender identity or expression, sexual orientation, national origin, disability, citizenship, veran status, genetic information, or any other characteristics protected by applicable state, federal or local laws. Our policy of equal employment opportunity and affirmative action applies to all employment decisions personnel policies and practices, or programs.

**Position:**
Embedded Engineer- Virtio Device Development (eInfochips Inc.)
**Job Description:**
**What candidate will Be Doing:**
+ Take high-level technical requirements and translate them into well-architected solutions, executing with minimal oversight.
+ Support both embedded/edge virtualization and cloud-based virtualized environments, ensuring scalability, performance, and reliability.
+ Develop and extend Virtio devices including virtio-audio, virtio-gpu, virtio-vsock, and virtio-net, with a deep understanding of Virtio specification internals.
+ Actively participate in R&D discussions and collaborate with standards bodies to shape the evolution of virtualization technologies.
+ Integrate virtualization solutions into cloud/container ecosystems leveraging AWS, Docker, Kubernetes, and CI/CD workflows.
+ Work cross-functionally with hardware, firmware, and software teams to troubleshoot and optimize virtualization frameworks.
**What we are looking for:**
+ VirtIO (device development & extensions).
+ Overall 8+ years of experience in Embedded side.
+ OASIS Virtio standards & Linux Kernel Virtio subsystems.
+ AWS, Docker, Kubernetes, CI/CD workflows for virtualized environments.
+ Embedded C, C++, Assembly.
**Work Arrangement Fully Onsite:** Must be able to travel to an Arrow Client office location as requested by Arrow Client leadership.
**Location:** Completed Onsite at Peachtree City, GA **.**
**What's In It for You:**
At Arrow, we recognize that financial rewards and great benefits are important aspects of an ideal job. That's why we offer competitive financial compensation, including various compensation plans and a solid benefits package.
+ Medical, Dental, Vision Insurance
+ 401k, With Matching Contributions
+ Short-Term/Long-Term Disability Insurance
+ Health Savings Account (HSA)/Health Reimbursement Account (HRA) Options
+ Paid Time Off (including sick, holiday, vacation, etc.)
+ Tuition Reimbursement
+ Growth Opportunities
+ And more!
**About eInfochips:** eInfochips **,** an Arrow company (Fortune #133), is a leading global provider of product engineering and semiconductor design services. A rich history of over two decades, with over 500+ products developed and 40M deployments in 140 countries, eInfochips continues to fuel technological innovations in multiple verticals. eInfochips has strategic technology partnerships with Qualcomm, NVIDIA, NXP, Analog Devices, Texas Instruments, Amazon, Microsoft and Google to name a few. Along with Arrow's $38B in revenues, 22,000 employees, and 345 locations serving over 80 countries, eInfochips is primed to accelerate connected products innovation for 150,000+ global clients. eInfochips acts as a catalyst to Arrow's Sensor-to-Sunset initiative and offers complete edge-to-cloud capabilities for its clients. Please visit for our portfolio of product engineering services across various industries & verticals.
**EEO Statement:** Arrow is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, gender, age, sexual orientation, gender identity, national origin, veteran or disability status. (Arrow EEO/AAP policy)
**Location:**
US-GA-Peachtree City-Georgia (Panasonic Auto)
**Time Type:**
Full time
**Job Category:**
Engineering Services
**EEO Statement:**
Arrow is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, gender, age, sexual orientation, gender identity, national origin, veteran or disability status. (Arrow EEO/AAP policy) ( anticipate this requisition will be open for a minimum of five days, though it may be open for a longer period of time. We encourage your prompt application._
Arrow Electronics, Inc.'s policy is to provide equal employment opportunities to all qualified employees and applicants without regard to race, color, religion, age, sex, marital status, gender identity or expression, sexual orientation, national origin, disability, citizenship, veran status, genetic information, or any other characteristics protected by applicable state, federal or local laws. Our policy of equal employment opportunity and affirmative action applies to all employment decisions personnel policies and practices, or programs.

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 TakedasPrivacy 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-termincentives. 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

YesIt 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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