Associate Principal Scientist/Engineer, Medical Device and Combination Products, ISO/DV Testing Manager
Merck · West Point, PA
ResearchFull-time$142k–$224kCompany career page
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Role summary
Associate Principal Scientist/Engineer position managing design verification testing and method validation for medical device and combination products within the Center for Packaging & Device Analytics. Responsible for overseeing internal and external laboratory activities, ensuring regulatory compliance, and leading analytical testing operations.
What they're looking for
- BS, MS, or PhD in Mechanical, Chemical, Biomedical Engineering, or Chemistry
- Minimum 3 years (PhD) or 6 years (BS/MS) in analytical testing industry role
- Experience working in cGMP or ISO 13485 certified analytical laboratory
- Strong knowledge of regulatory compliance: GMP, GDP, and quality assurance for analytical testing
- Demonstrated competency with mechanical testing methods and equipment
- Management or supervisory experience in cGMP or ISO 13485 laboratory environment
- Expertise in medical device development, Design Controls (21 CFR 820.30), and ISO 13485
What you'll be doing
- Manage and oversee design verification testing activities to meet commercial product timelines
- Provide technical oversight of method development, validation, and implementation at internal and external laboratories
- Ensure cGMP, ISO 13485 compliance, and safety standards across all laboratory operations
- Collaborate with program leads on test method development and new analytical technologies
- Coach and develop CPDA analysts within the ISO design verification laboratory
Privacy & handoff
This role links to Merck's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.