Senior Engineer, Device Technical Operations (Hybrid)
Merck · West Point, PA +1 more
The apply link worked recently (not employer-confirmed).
Role summary
Senior Engineer position within Device Development and Technology Organization responsible for engineering capabilities in medical device and combination product development, manufacturing scale-up, and commercialization. Focus on complex drug-delivery systems including autoinjectors, ophthalmic, and inhalation products, with emphasis on design transfer, regulatory compliance, and technology transfer support.
What they're looking for
- Bachelor's degree in mechanical, biomedical, chemical, or materials engineering
- Minimum 5 years pharmaceutical, biologic, or medical device engineering experience
- At least 2 years supporting commercial manufacturing operations
- Expertise in design controls, risk analysis, design verification testing, and process validation
- Technical experience in injection molding, automation, complex assembly and packaging
- Strong knowledge of ISO 13485, ISO 14971, and quality management systems
- Direct experience with autoinjectors, ophthalmic, or inhalation products preferred
What you'll be doing
- Apply design controls, design transfer, risk management, and verification testing to develop medical device solutions
- Support internal and external component and combination product manufacturing globally
- Identify manufacturing issues, perform root cause analysis, and provide technical solutions
- Develop strategic technology transfer plans and lead cross-functional teams through late-stage development
- Support regulatory inspections, pre-approval activities, and ensure compliance with quality standards
Privacy & handoff
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