Associate Principal Engineer, Drug-Device Combination Products

$142.4k - $224.1k

Merck

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

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Vacancy posted 10 days ago

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