Associate Principal Engineer, Drug-Device Combination Products

Associate Principal Engineer position leading cross-functional teams in drug-device combination product development at Merck's Device Development & Technology group. Role focuses on technical leadership, program delivery, and regulatory compliance for complex devices including autoinjectors, inhalers, and connected platforms.

Responsibilities

• Lead device development sub-teams through technical roadmaps, stage-gate reviews, and design freeze milestones
• Own design history file strategy and maintenance aligned with 21 CFR 820.30 and ISO 13485 requirements
• Oversee design verification and validation programs, including test methods, acceptance criteria, and gauge validation
• Manage technical deliverables from device OEMs and suppliers; interrogate manufacturing processes against specifications
• Author and defend device sections of global regulatory filings; respond to health authority information requests and inquiries

Requirements

• BS in Mechanical, Biomedical, Chemical Engineering, or Materials Science with 8+ years regulated industry experience; or MS with 6+ years; or PhD with 4+ years
• Demonstrated technical team leadership in cross-functional pharmaceutical, biotechnology, or medical device environment
• Comprehensive mastery of combination product regulations: 21 CFR Part 4, 21 CFR 820.30, ISO 13485, ISO 14971
• Strong mechanical aptitude with expertise in tolerance analysis, material compatibility, and mechanical testing
• Proven track record managing complex technical milestones and translating technical risks for executive audiences
• Experience with design control methodologies, design verification and validation, risk management frameworks
• Familiarity with regulatory submissions (IND, IMPD, BLA, NDA, MAA) and health authority interactions