Associate Principal Engineer, Drug-Device Combination Products
Merck
August 07, 2026
Remote friendly (Rahway, NJ)
United States
Operations
Responsibilities:
- Develop plans/strategies for combination product assembly process and equipment development; lead technical teams to deliver qualified process/equipment for clinical or commercial use.
- Author design/process FMEA; define risk controls for robust device functionality.
- Design/author process validation activities and documentation (IQ/OQ/PPQ).
- Author protocols/reports; create drawings and specifications per relevant SOPs.
- Design automated combination product assembly equipment; manage equipment suppliers.
- Develop, implement, troubleshoot assembly processes (e.g., vision systems, ultrasonic welding, automated component/glass feeding/handling).
- Manage manufacturing site readiness, including equipment qualification and associated documentation.
- Apply DFM/DFA principles and failure modes related to assembly processes.
- Collaborate on process/technology transfer to manufacturing facilities.
Qualifications:
- B.S. in Mechanical Engineering (or related); minimum 15 years regulated industry experience.
Required skills:
CAD modeling, CAD (Computer-Aided Design), design controls, DFMEA, design verification testing, device development, human factors engineering, medical device management/manufacturing/quality systems, QMS, risk control, test method validation; plus combination products.
Preferred skills:
- CAD design (SOLIDWORKS), 3D printing/prototyping; fabricate custom fixtures.
Benefits/Compensation (if applicable):
- Annual bonus and long-term incentive (if applicable); medical/dental/vision; 401(k); paid holidays/vacation; compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en. (Application deadline listed on posting.)
- Develop plans/strategies for combination product assembly process and equipment development; lead technical teams to deliver qualified process/equipment for clinical or commercial use.
- Author design/process FMEA; define risk controls for robust device functionality.
- Design/author process validation activities and documentation (IQ/OQ/PPQ).
- Author protocols/reports; create drawings and specifications per relevant SOPs.
- Design automated combination product assembly equipment; manage equipment suppliers.
- Develop, implement, troubleshoot assembly processes (e.g., vision systems, ultrasonic welding, automated component/glass feeding/handling).
- Manage manufacturing site readiness, including equipment qualification and associated documentation.
- Apply DFM/DFA principles and failure modes related to assembly processes.
- Collaborate on process/technology transfer to manufacturing facilities.
Qualifications:
- B.S. in Mechanical Engineering (or related); minimum 15 years regulated industry experience.
Required skills:
CAD modeling, CAD (Computer-Aided Design), design controls, DFMEA, design verification testing, device development, human factors engineering, medical device management/manufacturing/quality systems, QMS, risk control, test method validation; plus combination products.
Preferred skills:
- CAD design (SOLIDWORKS), 3D printing/prototyping; fabricate custom fixtures.
Benefits/Compensation (if applicable):
- Annual bonus and long-term incentive (if applicable); medical/dental/vision; 401(k); paid holidays/vacation; compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en. (Application deadline listed on posting.)