14 jobs in Biolinq
Senior Software Engineer/ iOS
Posted today
Job Viewed
Job Description
About the Company
Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.
Job PurposeThis role is a member of a team of engineers and scientists developing and commercializing novel intradermal biosensor technology. The role may have components in the development or commercialization facets of the department. It will require working across departments (operations, clinical trials, engineering, and marketing) to establish requirements and execute based on best software development practice.
Duties and Responsibilities- Works independently to produce working and tested software within the software discipline and language specialty of the engineer.
- Independently solves engineering problems for individual microservices or applications.
- Works with stakeholders to refine software requirements.
- Can use direct measurements to make estimates of load capacity, response time, or UI responsiveness for a microservice or application.
- Identifies and communicates trade-offs within a system design between competing solutions and regularly makes the best choice for the company.
- Can accurately estimate the time to complete projects of moderate complexity or scope (i.e. a full feature or microservice).
- Proposes and, with approval, implements projects that support the strategic objectives of the company.
- Writes and maintains unit tests to satisfy target code coverage.
- Produces documentation required by Biolinq's Quality System to maintain regulatory compliance.
- Prepares documentation necessary to install, operate, and maintain as needed. This may include design, installation guides, user guides, etc.
- Protects operations and customer confidentiality by keeping information confidential.
- Maintains existing Biolinq software including fixing bugs and enhancing features.
- Performs all other duties as assigned.
- This engineer will have confidence in at least one software discipline (i.e. mobile, server, or GUI) and language (i.e. GO, JavaScript, Swift, Kotlin, etc).
- BS or MS Degree in Electrical Engineering, Computer Engineering, Computer Science, or a scientific discipline with 5-8 years of experience in at least one discipline and language.
- Deployed and supported at least one application or service in a production environment.
- Demonstrated experience using established software principles to solve ambiguous problems.
- Familiarity with quality systems for software as a medical device.
- Has a solid understanding of threading and knows when to use pre-built libraries or threading primitives.
- Has a solid understanding of design principles and uses them when designing or refactoring software.
- Has a solid understanding of Agile principles and applies them to a regulated environment.
- Works collaboratively to drive solutions that satisfy the needs of the business.
General office of laboratory. May include 10% travel.
Physical RequirementsWhile performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift or move up to 15 pounds.
BenefitsMedical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.
Salary$140,000 to $160,000 annually.
Equal Opportunity Employer StatementAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The Company maintains a smoke‑free workplace.
Reasonable AccommodationIf you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at
#J-18808-LjbffrIs this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.
Senior Software Engineer, Wearable Health Tech
Posted today
Job Viewed
Job Description
Biolinq in Enid, Oklahoma, is seeking a software engineer to join its team in developing and commercializing a novel biosensor technology. The role requires collaboration across departments and a solid understanding of software engineering principles.
The ideal candidate has 5-8 years of experience, a relevant degree, and proficiency in languages such as GO or JavaScript. Comprehensive benefits including medical, dental, and a 401(k) plan are provided.
#J-18808-LjbffrIs this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.
Principal MEMS Microsystems Engineer for Biosensor R&D
Posted today
Job Viewed
Job Description
#J-18808-Ljbffr
Is this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.
Principal Microsystems Engineer - MEMS
Posted today
Job Viewed
Job Description
Job Type
Full-time
DescriptionWARNING about fake job posting scams. There has been a recent wave of scams whereby third parties post fake job openings using a bogus email address that resembles Under the guise of asking you to fill out an application, the scammers are attempting to gather your personal information. See the Federal Trade Commission’s warning on this topic at: The only official source for actual Biolinq job postings/openings is at While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit to verify the accuracy of the openings found on third party web sites.
About the CompanyBiolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.
Job PurposeThis is a key R&D role, requiring detailed knowledge of MEMS device design, process, and associated testing and characterization. You will help to optimize existing designs and processes to ensure a high-quality product. You will also work to define and realize the company’s future products through ideation, design, and instantiation of functional prototypes to be used in testing, including clinical trials. You will demonstrate sound analytical skills in evaluating processes and designs, considering manufacturing feasibility, functional and cost requirements, and design optimization trade-offs, with a deep understanding of the physical and chemical/biological mechanisms underpinning biosensor behavior.
Duties and Responsibilities- Design microneedle and other devices for novel biochemical sensors. Work with third-party manufacturing partners and internal supply chain teams to ensure high volume, cost effective, capable and stable processes, as demonstrated by experiment and statistical analysis.
- Develop in‑house tests, and work with third parties to develop tests used to characterize and verify/validate products.
- Develop useful in silico models for biosensor devices.
- Work with other technical team members to ensure product requirements are met via formal verification.
- Participate in failure analysis and tiger team activities.
- Within the Biolinq organization, be the champion and trusted educator/resource for MEMS related topics.
- Generate germane intellectual property for the company.
- Work with other technical team members to accelerate the rate of progress to generate high-quality products.
- M.S., or Ph.D. Degree in Electrical, Materials Science, Mechanical, or Chemical Engineering, along with a minimum of 8 years work experience with an MS, and 5 years with a Ph.D.
- Demonstrated successful completion (ready-for-production) of MEMS and/or Microfluidic devices.
- A demonstrated expertise and rigor for statistical analysis, design of experiments, and associated relevant tools.
- Experience with FEM modeling tools (i.e., Ansys, COMSOL), Mechanical Design tools (e.g., Solidworks) and Layout tools (e.g., L‑Edit) is strongly preferred. Experience developing Python (or other) for test, modeling, and statistical analysis is strongly preferred.
- Ability to interface with electrical, mechanical, chemical, and biomedical engineers and work in a fast‑paced, multidisciplinary environment. Capacity to manage multiple projects and communicate ideas clearly to the organization.
- Experience commercializing products for highly regulated markets (e.g., Medical, Automotive, Aerospace) is preferred.
- Experience with Physical and Chemical analysis techniques is preferred.
- A knack for thinking at the fundamental sensor transduction level, as well as the product system level, towards creating optimized and intuitive products.
General office or laboratory. May include 10% travel.
Physical RequirementsWhile performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift or move up to 15 pounds.
BenefitsMedical, dental, vision, health savings account, flexible spending account, life and long‑term disability insurance, 401(k) plan, holidays, and PTO.
SalaryThe U.S. base salary range reasonably expected to be paid for this role is: $160,000 to $200,000 per year. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package may also include an annual performance bonus and/or other applicable incentive compensation plans.
Equal Employment Opportunity StatementAt Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, the Company maintains a smoke‑free workplace.
As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process.
ContactIf you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at
#J-18808-LjbffrIs this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.
Senior Software Engineer/ iOS
Posted 2 days ago
Job Viewed
Job Description
WARNING about fake job posting scams
There has been a recent wave of scams whereby third parties post fake job openings using a bogus email address that resembles Under the guise of asking you to fill out an application, the scammers are attempting to gather your personal information. See the Federal Trade Commission’s warning on this topic at: The only official source for actual Biolinq job postings/openings is at While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit to verify the accuracy of the openings found on third party web sites.
About the CompanyBiolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.
Job PurposeThis role is as a member of a team of engineers and scientists developing and commercializing novel intradermal biosensor technology. The role may have components in the development or commercialization facets of the department. The role will be required to work across departments (operations, clinical trials, engineering, and marketing) to establish requirements and execute based on best software development practice.
Duties and Responsibilities- Works independently to produce working and tested software within the software discipline and language specialty of the engineer.
- Independently solves engineering problems for individual microservices or applications.
- Works with stakeholders to refine software requirements.
- Can use direct measurements to make estimates of load capacity, response time, or UI responsiveness for a microservice or application.
- Identifies and communicates trade-offs within a system design between competing solutions and regularly makes the best choice for the company.
- Can accurately estimate the time to complete projects of moderate complexity or scope (i.e. a full feature or microservice).
- Proposes and, with approval, implements projects that support the strategic objectives of the company.
- Writes and maintains unit tests to satisfy target code coverage.
- Produces documentation required by Biolinq’s Quality System to maintain regulatory compliance.
- Prepares documentation necessary to install, operate, and maintain as needed. This may include design, installation guides, user guides, etc.
- Protect operations and customer confidentiality by keeping information confidential.
- Maintains existing Biolinq software, including fixing bugs and enhancing features.
- Performs all other duties as assigned.
- This engineer will have a confidence in at least one software discipline (i.e. mobile, server, or GUI) and language (i.e. Go, JavaScript, Swift, Kotlin, etc).
- BS or MS Degree in Electrical Engineering, Computer Engineering, Computer Science, or scientific discipline with 5-8 years of experience at least one discipline and language.
- Deployed and supported at least one application or service in a production environment.
- Demonstrated experience using established software principles to solve ambiguous problems.
- Familiarity with quality systems for software as a medical device.
- Has a solid understanding of threading and knows when to use pre-built libraries or threading primitives.
- Has a solid understanding of design principles and uses them when designing or refactoring software.
- Has a solid understanding of Agile principles and applies them to a regulated environment.
- Works collaboratively to drive solutions that satisfy the needs of the business.
General office of laboratory. May include 10% travel.
Physical RequirementsWhile performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift or move up to 15 pounds.
BENEFITSMedical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.
Equal Employment OpportunityAt Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke-free workplace.
As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $140,000 to $160,000 per year. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.
Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at
#J-18808-LjbffrIs this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.
Senior Software Engineer — Medical Device SDK
Posted 2 days ago
Job Viewed
Job Description
Biolinq in San Diego is looking for a skilled engineer to develop and commercialize innovative intradermal biosensor technology. This role involves working closely with cross-functional teams in operations, clinical trials, engineering, and marketing to achieve project objectives.
The ideal candidate should have a degree in engineering or computer science and a solid background in software development, along with excellent collaboration skills. Competitive compensation and comprehensive benefits are provided.
#J-18808-LjbffrIs this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.
Senior Process Development Engineer - Scale-Up
Posted 2 days ago
Job Viewed
Job Description
#J-18808-Ljbffr
Is this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.
Process Development Engineer IV (Staff)
Posted 2 days ago
Job Viewed
Job Description
Overview
Description \u00a0\u00a0WARNING about fake job posting scams. There has been a recent wave of scams whereby third parties post fake job openings using a bogus email address that resembles Under the guise of asking you to fill out an application, the scammers are attempting to gather your personal information. See the Federal Trade Commission’s warning on this topic at:
The only official source for actual Biolinq job postings/openings is at While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit to verify the accuracy of the openings found on third party web sites.
About the CompanyBiolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.
Job PurposeResponsible for activities and area goals through design, development, and transfer at the component and finished product level;
Roles and Responsibilities- Support R&D on identifying critical to quality attributes (CQAs), test development, characterization, and specifications;
- Validate critical in-process test methods to demonstrate suitability for intended use;
- Identify opportunities to scale and automate test methods for capacity and capability;
- Develop trace matrix linking user needs, design, inputs, and system and sub-system requirements to process specifications (PSD);
- Identify “leap” technologies enabling scale, demonstrate proof of concept and business case, and down-select for implementation into manufacturing pipeline;
- Manage equipment lifecycle through requirements (URS, ERD), concept, site acceptance (FAT, SAT), and induction (EB, IQ);
- Develop processes, fixtures, and equipment that meet business and manufacturing needs;
- Design experiments to baseline, characterize, and optimize process variables;
- Define preventative maintenance and setup procedures for new equipment;
- Develop test plan, qualification templates, and risk assessments for process validation;
- Complete initial line qualification activities to support regulatory filing and product launch (MVP, OQ/PQ/PV)
- Develop production control plan to monitor product consistency in manufacturing;
- Develop pilot manufacturing layout and cell design for product flow;
- Support delivery of pre-commercial builds for unreleased product or process iterations;
- Release documents for build traceability of new product or process iterations (MPI, DHR);
- Provide capital requirements for capacity and budget planning;
- Integrate lessons learned and opportunities from current product into future generations;
- Provide input to ensure product is designed for manufacturability and assembly (DFM);
- Maintain repository of key insights and tribal knowledge for sustaining engineering team;
- Characterize noise factors (storage, environment, etc.) and process cliffs for scaling robustness;
- Collaborate with R&D and Supply Chain to model product cost for anticipated volumes;
- Assess viability of product and process to meet manufacturing and business needs;
- Document engineering tradeoffs and deferred changes for process transfer;
- Complete supporting documents for design transfer (DHF, DMR, etc.);
- Provide technical input for product- and manufacturing-related non-conformances, risk management, and manufacturing strategy;
- Re-evaluate manufacturing release criteria for yield and/or performance improvement;
- Participate in review meetings to align on production performance and strategic initiatives;
- Implement new manufacturing equipment to support scaling, including at key suppliers;
- Execute strategic initiatives to increase capacity and meet anticipated scaling needs;
- Implement advanced manufacturing strategies to support maturation of technologies and competencies needed for high-volume manufacturing;
- Design or modify equipment and fixtures to mitigate variation sources in manufacturing;
- Complete change impact assessment to align implementation plan for proposed changes;
- Evaluate and implement 2nd source materials for manufacturing supply risk;
- Develop qualification process to evaluate performance of incoming raw material lots;
- Support evaluation, selection, development, and qualification of key suppliers;
- Develop test methods and material specifications for critical components;
- Characterize product impact of sterilization, shipping, and storage for commercial flexibility;
- BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required
- Minimum 8-12 years related experience, including years of higher-level education (MS, PhD)
- Experience in design of experiments and statistical tools (ANOVA, t-test, etc.)
- Experience with Fishbone, A3, 5Y, and other root cause investigation tools
- Strong understanding of process interactions (inputs, outputs) that are both technical and system related
- Expertise with scaling manufacturing processes to commercial volumes
- Experience with budgeting, cost management, modeling, and preparing business proposals (ROI, NPV) for new initiatives seeking executive approval
- Strong understanding of FDA 21 CFR Part 820 and ISO 13485 quality and regulatory standards
- Experience with lean manufacturing and six sigma methodologies (preferred)
- Experience with design for manufacturability concepts and product development lifecycle (preferred)
- Experience with standard electrical, mechanical, and wet lab test equipment (preferred)
- Strong leadership skills, including the ability to set goals, allocate resources to appropriate priorities, and provide constructive feedback to foster positive relationships
- Proficiency in Microsoft Office tools
- Proficiency with JMP, Minitab, or equivalent statistical software
- Experience with ERP, MES, and other manufacturing systems
- Proficiency in BMRAM or equivalent asset management system
- Expertise in several specialty skillset, including injection molding, welding, analytical chemistry, microscopy, metrology, adhesives, or electronics packaging
- Proficiency in Solidworks or equivalent CAD software (preferred)
- Experience with MS Project, Visio, and other project management tools (preferred)
- Experience with manufacturing database, controls, and vision (preferred)
- Experience with Altium or other electronics design software (preferred)
- Role model for what kindness looks like. Actively levels up those on the team through example setting, guidance, and support. Empowers others to make effective decisions
- Excels at identifying solutions to accelerate teams learning of the problem space
- Strong organizational planning and ability to hold others accountable. Breaks down silos within and across teams to ensure forward progress and collective success
- Ability to take decisive action and deliver tangible results in a cross-functional organization. Leadership aptitude of teams, projects, and programs
General Office, Laboratory, and Cleanroom environments
Expected travel less than 10%
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.
BenefitsMedical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.
At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.
As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $130,000 to $155,000. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.
Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at
#J-18808-LjbffrIs this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.
Process Development Engineer IV (Staff)
Posted 2 days ago
Job Viewed
Job Description
Overview
Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.
Job PurposeResponsible for activities and area goals through design, development, and transfer at the component and finished product level.
Responsibilities- Support R&D on identifying critical to quality attributes (CQAs), test development, characterization, and specifications.
- Validate critical in-process test methods to demonstrate suitability for intended use.
- Identify opportunities to scale and automate test methods for capacity and capability.
- Develop trace matrix linking user needs, design, inputs, and system and sub-system requirements to process specifications (PSD).
- Identify “leap” technologies enabling scale, demonstrate proof of concept and business case, and down-select for implementation into manufacturing pipeline.
- Manage equipment lifecycle through requirements (URS, ERD), concept, site acceptance (FAT, SAT), and induction (EB, IQ).
- Develop processes, fixtures, and equipment that meet business and manufacturing needs.
- Design experiments to baseline, characterize, and optimize process variables.
- Define preventative maintenance and setup procedures for new equipment.
- Develop test plan, qualification templates, and risk assessments for process validation.
- Complete initial line qualification activities to support regulatory filing and product launch (MVP, OQ/PQ/PV).
- Develop production control plan to monitor product consistency in manufacturing.
- Develop pilot manufacturing layout and cell design for product flow.
- Support delivery of pre-commercial builds for unreleased product or process iterations.
- Release documents for build traceability of new product or process iterations (MPI, DHR).
- Provide capital requirements for capacity and budget planning.
- Integrate lessons learned and opportunities from current product into future generations.
- Provide input to ensure product is designed for manufacturability and assembly (DFM).
- Maintain repository of key insights and tribal knowledge for sustaining engineering team.
- Characterize noise factors (storage, environment, etc.) and process cliffs for scaling robustness.
- Collaborate with R&D and Supply Chain to model product cost for anticipated volumes.
- Assess viability of product and process to meet manufacturing and business needs.
- Document engineering tradeoffs and deferred changes for process transfer.
- Complete supporting documents for design transfer (DHF, DMR, etc.).
- Provide technical input for product- and manufacturing-related non-conformances, risk management, and manufacturing strategy.
- Re-evaluate manufacturing release criteria for yield and/or performance improvement.
- Participate in review meetings to align on production performance and strategic initiatives.
- Implement new manufacturing equipment to support scaling, including at key suppliers.
- Execute strategic initiatives to increase capacity and meet anticipated scaling needs.
- Implement advanced manufacturing strategies to support maturation of technologies and competencies needed for high-volume manufacturing.
- Design or modify equipment and fixtures to mitigate variation sources in manufacturing.
- Complete change impact assessment to align implementation plan for proposed changes.
- Evaluate and implement 2nd source materials for manufacturing supply risk.
- Develop qualification process to evaluate performance of incoming raw material lots.
- Support evaluation, selection, development, and qualification of key suppliers.
- Develop test methods and material specifications for critical components.
- Characterize product impact of sterilization, shipping, and storage for commercial flexibility.
- BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required.
- Minimum 8-12 years related experience, including years of higher-level education (MS, PhD).
- Experience in design of experiments and statistical tools (ANOVA, t-test, etc.).
- Experience with root cause investigation tools (Fishbone, A3, 5Y, etc.).
- Strong understanding of process interactions (inputs, outputs) that are technical and system related.
- Expertise with scaling manufacturing processes to commercial volumes.
- Experience with budgeting, cost management, modeling, and preparing business proposals (ROI, NPV).
- Strong understanding of FDA 21 CFR Part 820 and ISO 13485 quality and regulatory standards.
- Experience with lean manufacturing and six sigma methodologies (preferred).
- Experience with design for manufacturability concepts and product development lifecycle (preferred).
- Experience with standard electrical, mechanical, and wet lab test equipment (preferred).
- Strong leadership skills and ability to foster collaboration and accountability.
- Proficiency in Microsoft Office tools; experience with JMP, Minitab, or equivalent software.
- Experience with ERP, MES, and other manufacturing systems; proficiency in asset management systems (e.g., BMRAM) is a plus.
- Experience with CAD software (SolidWorks preferred); familiarity with MS Project, Visio (preferred).
- Experience with manufacturing database, controls, and vision (preferred); with electronics design software (Altium) preferred.
- Ability to lead cross-functional teams and drive results; demonstrated kindness and ability to elevate others.
General Office, Laboratory, and Cleanroom environments. Expected travel less than 10%.
BenefitsMedical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.
EEO and AccommodationsAt Biolinq we fully subscribe to the principles of Equal Employment Opportunity. We provide equal opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, veteran status, disability, or any other basis prohibited by law. Reasonable accommodations may be provided during the application process. Biolinq is an Equal Opportunity Employer. If you need a reasonable accommodation during the hiring process, contact Biolinq Talent Acquisition at
Note: The information herein may be subject to change. Pay transparency: U.S. base salary range for this role is $130,000 to $155,000. Total compensation may include bonuses and other incentives, based on experience and location. More details shared by the recruiter during hiring.
#J-18808-LjbffrIs this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.
Senior Process Development Engineer, Scale-Up
Posted 2 days ago
Job Viewed
Job Description
#J-18808-Ljbffr
Is this job a match or a miss?
Note: If you’re asked to pay for a job, avoid the role and report the job to us immediately.