Manager, Combination Product Development
Insmed Incorporated
August 07, 2026
Remote friendly (Bridgewater, NJ)
United States
Operations
Manager, Combination Product Development (Manufacturing, Science and Technology)
What You’ll Do
- Generate process, product, and life cycle metrics via statistical analysis
- Participate in Management Review for combination product quality metrics
- Review PQC monthly metrics
- Conduct risk assessment/analysis and maintain risk management file including annual review of UFMEA
- Perform technical assessments to update 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; organize regular technical meetings
- Draft NDA amendments for major changes
- Own device change technical assessment and change control process
- Perform technical review of 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 (Qualifications/Requirements)
- Bachelor’s degree + 5 years in engineering/operations
- Design Control and Risk Management experience
- CAPA lifecycle experience including root cause investigations (RCA techniques)
- Change Control experience
- Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485:2016, ISO 14971:2007, and EU Medical Device Regulation
- Excellent verbal and written communication
- Highly organized with strong attention to detail and clarity
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Nice to Have (Preferred)
- Certified Quality Engineer (or similar)
- Statistical expertise (e.g., Minitab)
Where You’ll Work / Travel / Pay
- Hybrid role (Bridgewater, NJ); remote most of the time
- Occasional global travel ~5%–10%
- $124,000.00–161,000.00 annual
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday.
What You’ll Do
- Generate process, product, and life cycle metrics via statistical analysis
- Participate in Management Review for combination product quality metrics
- Review PQC monthly metrics
- Conduct risk assessment/analysis and maintain risk management file including annual review of UFMEA
- Perform technical assessments to update 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; organize regular technical meetings
- Draft NDA amendments for major changes
- Own device change technical assessment and change control process
- Perform technical review of 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 (Qualifications/Requirements)
- Bachelor’s degree + 5 years in engineering/operations
- Design Control and Risk Management experience
- CAPA lifecycle experience including root cause investigations (RCA techniques)
- Change Control experience
- Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485:2016, ISO 14971:2007, and EU Medical Device Regulation
- Excellent verbal and written communication
- Highly organized with strong attention to detail and clarity
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Nice to Have (Preferred)
- Certified Quality Engineer (or similar)
- Statistical expertise (e.g., Minitab)
Where You’ll Work / Travel / Pay
- Hybrid role (Bridgewater, NJ); remote most of the time
- Occasional global travel ~5%–10%
- $124,000.00–161,000.00 annual
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday.