Manager, Combination Product Development
Insmed Incorporated
August 29, 2026
Remote friendly (Bridgewater, NJ)
United States
Operations
About The Role
We’re looking for a Manager, Combination Product Development on the Manufacturing, Science and Technology team. Reporting to the Director, Combination Product Development, you’ll support manufacturing operations by analyzing data and initiating manufacturing investigations, deviations and change controls, and developing actions to improve process robustness and product quality related to device development and combination product development.
What You'll Do
- Generate process, product, and life cycle metrics via statistical analysis
- Participate in Management Review for combination products quality metrics
- Review PQC monthly metrics
- Conduct risk assessment/analysis and maintain the risk management file, including annual UFMEA review
- Perform technical assessments to update the Design History File for design/process changes
- Lead complaint trend investigations (combination product and/or device)
- Lead manufacturing investigations (combination product and/or device)
- Serve as point of contact for the device manufacturer and organize regular technical meetings
- Draft NDA amendments for major changes
- Own the change control process (device technical assessment for changes)
- Review labeling, IFU, and training material changes
- Represent in CMC meetings to assess device/combination product impact
- Work effectively with cross-functional teams
- Experience in GxP systems
Who You Are
- Bachelor’s degree + 5 years in engineering/operations
- Required: Design Control and Risk Management; CAPA lifecycle (incl. RCA techniques); Change Control; working knowledge of FDA 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007, EU Medical Device Regulation
- Excellent verbal and written communication; highly organized; detail-oriented; proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Nice to Have (but Not Required)
- Certified Quality Engineer (or similar)
- Statistical expertise (e.g., Minitab)
Where You’ll Work / Travel
Hybrid (Bridgewater, NJ); occasional global travel ~5%–10%
Pay Range
$124,000–$161,000 annual
Application Instructions
Current Insmed employees: apply via Jobs Hub in Workday.
We’re looking for a Manager, Combination Product Development on the Manufacturing, Science and Technology team. Reporting to the Director, Combination Product Development, you’ll support manufacturing operations by analyzing data and initiating manufacturing investigations, deviations and change controls, and developing actions to improve process robustness and product quality related to device development and combination product development.
What You'll Do
- Generate process, product, and life cycle metrics via statistical analysis
- Participate in Management Review for combination products quality metrics
- Review PQC monthly metrics
- Conduct risk assessment/analysis and maintain the risk management file, including annual UFMEA review
- Perform technical assessments to update the Design History File for design/process changes
- Lead complaint trend investigations (combination product and/or device)
- Lead manufacturing investigations (combination product and/or device)
- Serve as point of contact for the device manufacturer and organize regular technical meetings
- Draft NDA amendments for major changes
- Own the change control process (device technical assessment for changes)
- Review labeling, IFU, and training material changes
- Represent in CMC meetings to assess device/combination product impact
- Work effectively with cross-functional teams
- Experience in GxP systems
Who You Are
- Bachelor’s degree + 5 years in engineering/operations
- Required: Design Control and Risk Management; CAPA lifecycle (incl. RCA techniques); Change Control; working knowledge of FDA 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007, EU Medical Device Regulation
- Excellent verbal and written communication; highly organized; detail-oriented; proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Nice to Have (but Not Required)
- Certified Quality Engineer (or similar)
- Statistical expertise (e.g., Minitab)
Where You’ll Work / Travel
Hybrid (Bridgewater, NJ); occasional global travel ~5%–10%
Pay Range
$124,000–$161,000 annual
Application Instructions
Current Insmed employees: apply via Jobs Hub in Workday.