Senior Staff Device Engineer
SoTalent · Lexington, MA
FULL-TIME
Posted Sep 7, 2026
Job Description
Senior Staff Device Engineer – Combination Products / Drug Delivery Devices
Location: Lexington, Massachusetts, USA
Industry: Pharmaceutical / Biotechnology / Medical Devices
Employment Type: Full-time, Regular
Work Arrangement: On-site
Compensation: $137,000–$215,270 base salary
About the Role
A leading pharmaceutical and life sciences organisation is seeking a Senior Staff Device Engineer to serve as a technical subject matter expert for commercial combination products and drug delivery devices.
The role is responsible for the technical lifecycle management of on-market combination products, covering device engineering, change controls, manufacturing process validation, complaint investigations, design controls, technical risk management and post-market surveillance.
Working within a highly cross-functional environment, the position partners with Drug Product, Quality, Regulatory, Manufacturing, Program Leadership and external development and manufacturing organisations to maintain compliant, reliable and commercially viable drug delivery systems.
Key Responsibilities
- Act as the technical lead and subject matter expert for commercial combination products throughout their lifecycle.
- Provide technical leadership for on-market drug delivery devices and systems.
- Support lifecycle management activities across commercial combination products.
- Conduct technical investigations related to manufacturing processes, commercial expansion and product performance.
- Oversee commercial device qualification activities.
- Coordinate technology transfer activities involving device verification and validation.
- Troubleshoot and resolve technical issues associated with commercial products.
- Provide technical input into change controls, medical device reporting (MDR) and post-market surveillance activities.
- Lead technical gap assessments and remediation activities.
- Guide risk-management activities from a device engineering perspective.
- Lead defined technical project activities within agreed timelines and budgets.
- Support device complaint handling, including technical assessment, root-cause analysis, CAPA and change control.
- Apply design-control principles throughout product development and lifecycle management.
- Develop and maintain product specifications, user requirements, verification and validation documentation.
- Develop technical test protocols, reports, assessments and related documentation.
- Support design transfer and manufacturing expansion activities.
- Lead or support manufacturing process validation.
- Ensure technical activities comply with applicable quality systems, regulatory requirements and company standards.
- Maintain and review Design History Files (DHF) and related technical documentation.
- Collaborate with external contract laboratories and manufacturing organisations.
- Establish effective working relationships across technical, quality, regulatory and commercial functions.
- Provide expert technical advice to project teams and senior stakeholders.
Product & Technical Expertise
Strong experience with medical devices and drug delivery systems, including combination products such as:
- Pre-filled syringes (PFS)
- Pen injectors
- Autoinjectors
- Needle safety devices
- Other injectable drug delivery systems
Experience should include commercial product lifecycle management and the associated engineering, manufacturing, quality and regulatory requirements.
Requirements
- PhD in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or a related technical discipline with
3+ years of relevant experience; or
- Master's degree with 5+ years of relevant experience; or
- Bachelor's degree with 8+ years of relevant experience.
- Strong subject matter expertise in medical devices, particularly drug delivery systems.
- Demonstrated technical leadership of commercialised drug delivery devices and combination products.
- Strong knowledge of design controls and medical device quality systems.
- Experience managing combination product lifecycle activities, including:
- Change controls
- Complaint investigations
- Manufacturing expansion
- Process validation
- Quality and regulatory support
- Post-market surveillance
- Strong knowledge and practical application of cGMP requirements and relevant industry standards.
- Understanding of combination product regulatory guidance.
- Strong understanding of manufacturing processes and packaging construction methods.
- Experience authoring technical documentation, including user requirements, protocols, reports and assessments.
- Previous experience supporting technology transfer.
- Hands-on experience with concept development and feasibility testing.
- Experience developing and validating test methods.
- Strong problem-solving and analytical capabilities.
- Excellent written, verbal and technical communication skills.
- Ability to manage multiple stakeholders and competing priorities.
- Proven ability to lead cross-functional technical teams and deliver projects against timelines.
Regulatory & Quality Knowledge
Experience with relevant medical device and combination product frameworks, including:
- cGMP
- Design Controls
- DHF – Design History File
- MDR – Medical Device Reporting
- ISO 13485
- ISO 14971
- Combination Product Regulatory Guidance
- Risk Management
- CAPA
- Change Control
- Manufacturing Process Validation
- Post-Market Surveillance
Key Skills
Medical Devices Combination Products Drug Delivery Devices Device Engineering Senior Device Engineer Drug Delivery Systems Autoinjectors Pen Injectors Pre-Filled Syringes PFS Needle Safety Devices Device Lifecycle Management Design Controls Design Verification Design Validation Design Transfer Technology Transfer Process Validation Complaint Handling Root Cause Analysis CAPA Change Control Risk Management Post-Market Surveillance cGMP ISO 13485 ISO 14971 MDR Manufacturing Expansion Technical Leadership Pharmaceutical Engineering
Compensation & Benefits
- Base salary range of $137,000–$215,270.
- Medical, dental and vision coverage.
- 401(k) with company match and annual retirement contribution.
- Health and wellness programmes.
- Paid vacation with the option to purchase additional vacation days.
- Family planning support.
- Tuition reimbursement.
- Flexible ways of working.
- Community outreach and charitable contribution programmes.
Location: Lexington, Massachusetts, USA
Industry: Pharmaceutical / Biotechnology / Medical Devices
Employment Type: Full-time, Regular
Work Arrangement: On-site
Compensation: $137,000–$215,270 base salary
About the Role
A leading pharmaceutical and life sciences organisation is seeking a Senior Staff Device Engineer to serve as a technical subject matter expert for commercial combination products and drug delivery devices.
The role is responsible for the technical lifecycle management of on-market combination products, covering device engineering, change controls, manufacturing process validation, complaint investigations, design controls, technical risk management and post-market surveillance.
Working within a highly cross-functional environment, the position partners with Drug Product, Quality, Regulatory, Manufacturing, Program Leadership and external development and manufacturing organisations to maintain compliant, reliable and commercially viable drug delivery systems.
Key Responsibilities
- Act as the technical lead and subject matter expert for commercial combination products throughout their lifecycle.
- Provide technical leadership for on-market drug delivery devices and systems.
- Support lifecycle management activities across commercial combination products.
- Conduct technical investigations related to manufacturing processes, commercial expansion and product performance.
- Oversee commercial device qualification activities.
- Coordinate technology transfer activities involving device verification and validation.
- Troubleshoot and resolve technical issues associated with commercial products.
- Provide technical input into change controls, medical device reporting (MDR) and post-market surveillance activities.
- Lead technical gap assessments and remediation activities.
- Guide risk-management activities from a device engineering perspective.
- Lead defined technical project activities within agreed timelines and budgets.
- Support device complaint handling, including technical assessment, root-cause analysis, CAPA and change control.
- Apply design-control principles throughout product development and lifecycle management.
- Develop and maintain product specifications, user requirements, verification and validation documentation.
- Develop technical test protocols, reports, assessments and related documentation.
- Support design transfer and manufacturing expansion activities.
- Lead or support manufacturing process validation.
- Ensure technical activities comply with applicable quality systems, regulatory requirements and company standards.
- Maintain and review Design History Files (DHF) and related technical documentation.
- Collaborate with external contract laboratories and manufacturing organisations.
- Establish effective working relationships across technical, quality, regulatory and commercial functions.
- Provide expert technical advice to project teams and senior stakeholders.
Product & Technical Expertise
Strong experience with medical devices and drug delivery systems, including combination products such as:
- Pre-filled syringes (PFS)
- Pen injectors
- Autoinjectors
- Needle safety devices
- Other injectable drug delivery systems
Experience should include commercial product lifecycle management and the associated engineering, manufacturing, quality and regulatory requirements.
Requirements
- PhD in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or a related technical discipline with
3+ years of relevant experience; or
- Master's degree with 5+ years of relevant experience; or
- Bachelor's degree with 8+ years of relevant experience.
- Strong subject matter expertise in medical devices, particularly drug delivery systems.
- Demonstrated technical leadership of commercialised drug delivery devices and combination products.
- Strong knowledge of design controls and medical device quality systems.
- Experience managing combination product lifecycle activities, including:
- Change controls
- Complaint investigations
- Manufacturing expansion
- Process validation
- Quality and regulatory support
- Post-market surveillance
- Strong knowledge and practical application of cGMP requirements and relevant industry standards.
- Understanding of combination product regulatory guidance.
- Strong understanding of manufacturing processes and packaging construction methods.
- Experience authoring technical documentation, including user requirements, protocols, reports and assessments.
- Previous experience supporting technology transfer.
- Hands-on experience with concept development and feasibility testing.
- Experience developing and validating test methods.
- Strong problem-solving and analytical capabilities.
- Excellent written, verbal and technical communication skills.
- Ability to manage multiple stakeholders and competing priorities.
- Proven ability to lead cross-functional technical teams and deliver projects against timelines.
Regulatory & Quality Knowledge
Experience with relevant medical device and combination product frameworks, including:
- cGMP
- Design Controls
- DHF – Design History File
- MDR – Medical Device Reporting
- ISO 13485
- ISO 14971
- Combination Product Regulatory Guidance
- Risk Management
- CAPA
- Change Control
- Manufacturing Process Validation
- Post-Market Surveillance
Key Skills
Medical Devices Combination Products Drug Delivery Devices Device Engineering Senior Device Engineer Drug Delivery Systems Autoinjectors Pen Injectors Pre-Filled Syringes PFS Needle Safety Devices Device Lifecycle Management Design Controls Design Verification Design Validation Design Transfer Technology Transfer Process Validation Complaint Handling Root Cause Analysis CAPA Change Control Risk Management Post-Market Surveillance cGMP ISO 13485 ISO 14971 MDR Manufacturing Expansion Technical Leadership Pharmaceutical Engineering
Compensation & Benefits
- Base salary range of $137,000–$215,270.
- Medical, dental and vision coverage.
- 401(k) with company match and annual retirement contribution.
- Health and wellness programmes.
- Paid vacation with the option to purchase additional vacation days.
- Family planning support.
- Tuition reimbursement.
- Flexible ways of working.
- Community outreach and charitable contribution programmes.
Benefits
- Health Insurance
- Dental Insurance
Additional Details
- City
- Lexington
- State
- Massachusetts
- Country
- US
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