Manager, Combination Product Development

About the role

We're seeking a Manager, Combination Product Development for our Manufacturing, Science and Technology team. Reporting to the Director, Combination Product Development, you'll support manufacturing operations by analyzing data and initiating investigations, deviations, and change controls to improve process robustness and product quality related to device development and combination product development.

Responsibilities

• Generate process, product, and life cycle related metrics through statistical analysis
• Participate in Management Review related to combination products quality metrics
• Review PQC monthly metrics
• Risk assessment/analysis/Risk management file including annual review of UFMEA
• Lead complaint trend investigations involving combination product and/or device
• Lead Manufacturing investigations involving combination product and/or device
• Point of contact for the Device manufacturer including organizing regular technical meetings with Device Manufacturer
• Draft NDA amendments for any major changes
• Perform device changes technical assessment and own the change control process for the change
• Perform technical Review of any labeling, IFU, and training material changes
• Representative in CMC meeting responsible to assess device and combination product impact

Requirements

• Bachelor’s degree along with 5 years of experience in engineering/operations
• Design Control and Risk Management experience required
• CAPA lifecycle experience, including root cause investigation including Root cause analysis (RCA) techniques required
• Change Control experience required
• Working knowledge of FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007, EU Medical Device Regulation is required
• Excellent communication skills (verbal and written)
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Qualifications

• Nice to have (but not required): Certified Quality Engineer or similar preferred, Statistical expertise preferred (Minitab or other statistical tools experience)

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP). Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration are also provided. The 401(k) plan includes a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance. Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back are also available.

Pay

$124,000.00 - $161,000.00 Annual

Schedule

This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most.

Travel

This role requires occasional global travel (approximately 5%–10%).