Associate Principal Engineer, Drug-Device Combination Products
Merck
June 25, 2026
Remote friendly (Rahway, NJ)
United States
Operations
Hands-on medical device product manufacturing and assembly engineer in the Device Development & Technology (DD&T) group.
Responsibilities:
- Develop detailed plans/strategies for combination product assembly process and equipment development; lead technical team to deliver qualified processes/equipment for clinical or commercial use.
- Author design/process FMEA; define appropriate risk controls.
- Design and author process validation documentation (IQ/OQ/PPQ, etc.).
- Author protocols/reports and create drawings/specifications per relevant SOPs.
- Design automated combination product assembly equipment and manage equipment suppliers.
- Develop/implement/troubleshoot assembly equipment processes (e.g., vision systems, ultrasonic welding, automated component/glass feeding/handling).
- Manage manufacturing site readiness, including equipment qualification and documentation.
- Apply DFM/DFA principles and design/failure modes related to assembly processes.
- Provide mechanical aptitude hands-on troubleshooting in lab and manufacturing floor settings; collaborate with internal sites and medical device suppliers/sub-suppliers.
- Support process and technology transfer to manufacturing facilities.
Qualifications:
- B.S. in Mechanical Engineering (or related) with 10+ years regulated industry experience with medical devices and/or drug-device combination products.
Preferred:
- CAD design knowledge (SOLIDWORKS); 3D printing; ability to prototype/fabricate custom fixtures.
Skills (required):
- Design controls; DFMEA/PFMEA; equipment qualification/validation; risk control; technical project management; manufacturing operations; data analysis; troubleshooting; strong oral/written communication; teamwork.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline stated on posting.
Responsibilities:
- Develop detailed plans/strategies for combination product assembly process and equipment development; lead technical team to deliver qualified processes/equipment for clinical or commercial use.
- Author design/process FMEA; define appropriate risk controls.
- Design and author process validation documentation (IQ/OQ/PPQ, etc.).
- Author protocols/reports and create drawings/specifications per relevant SOPs.
- Design automated combination product assembly equipment and manage equipment suppliers.
- Develop/implement/troubleshoot assembly equipment processes (e.g., vision systems, ultrasonic welding, automated component/glass feeding/handling).
- Manage manufacturing site readiness, including equipment qualification and documentation.
- Apply DFM/DFA principles and design/failure modes related to assembly processes.
- Provide mechanical aptitude hands-on troubleshooting in lab and manufacturing floor settings; collaborate with internal sites and medical device suppliers/sub-suppliers.
- Support process and technology transfer to manufacturing facilities.
Qualifications:
- B.S. in Mechanical Engineering (or related) with 10+ years regulated industry experience with medical devices and/or drug-device combination products.
Preferred:
- CAD design knowledge (SOLIDWORKS); 3D printing; ability to prototype/fabricate custom fixtures.
Skills (required):
- Design controls; DFMEA/PFMEA; equipment qualification/validation; risk control; technical project management; manufacturing operations; data analysis; troubleshooting; strong oral/written communication; teamwork.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline stated on posting.