Senior Engineer, Drug-Device Combination Products

Education / Minimum Requirement:
- B.S. in Mechanical Engineering (or related) with 8+ years of regulated industry experience

Responsibilities / Required Skills:
- Develop, implement, and troubleshoot combination product assembly equipment processes (incl. vision systems, ultrasonic welding, automated component and glass feeding/handling)
- Author design/process FMEA and identify risk controls for robust device functionality
- Design and author process validation activities and documentation (IQ/OQ/PPQ)
- Author protocols, reports, and create drawings/specifications per relevant SOPs
- Apply device/combination product DFM/DFA principles and understand design/failure modes related to assembly processes
- Provide excellent oral/written communication and present complex information to stakeholders
- Perform hands-on troubleshooting; work independently in lab and manufacturing settings
- Support process and technology transfer to manufacturing facilities
- Interface with internal sites and medical device suppliers/sub-suppliers; interrogate supplier processes vs. combination product specifications and critical quality attributes

Preferred Skills:
- CAD design (SOLIDWORKS)
- 3D printing; prototype/fabricate custom fixtures for assembly and testing

Benefits / Compensation (if applicable in posting):
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401k), paid holidays/vacation, compassionate and sick days

Application:
- Apply at https://jobs.merck.com/us/en (deadline listed on the posting). Requisition ID: R405444.