Associate Principal Engineer, Drug-Device Combination Products

MSD • Rahway, NJ

9h • Hybrid

About The Position

The Associate Principal Engineer works in the Device Development & Technology (DD&T) group within the Research division. DD&T develops devices, combination products, processes, testing and assembly equipment from conception through product launch, and supports commercially launched products. Products include autoinjectors, inhalers, implants, infusion pumps, vaginal rings, and connected devices/apps.

This technical leadership role directs cross-functional engineering teams and external partners in delivering complex combination product development programs. The position provides technical leadership, coordinates program execution, and represents the device constituent part on integrated development teams. It is accountable for aligning program milestones, design verification, manufacturing readiness, and regulatory compliance with clinical supply, formulation, filling operations, and regulatory submission needs. The role also mentors engineers and advances DD&T practices.

Requirements

• Bachelor of Science in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or a related engineering discipline and 8 or more years of progressive regulated-industry experience in medical device or combination product development; or a relevant Master of Science and 6 or more years of relevant experience; or a relevant Ph.D. and 4 or more years of relevant experience.
• Proven experience leading cross-functional engineering teams or sub-teams in a matrixed pharmaceutical, biotechnology, or medical device development environment.
• Comprehensive knowledge of combination product regulations and design control standards, including 21 CFR Part 4, 21 CFR 820.30, ISO 13485, and ISO 14971.
• Demonstrated ability to manage complex technical milestones, balance interdisciplinary priorities, and communicate technical risks in clear, executive-level summaries to senior leaders and partner groups.
• Strong mechanical aptitude, statistical analysis capability, and first-principles engineering depth, including tolerance stack analysis, material compatibility, and mechanical testing, to critically review, approve, and challenge technical work packages.
• Proven expertise facilitating and authoring system/device DFMEAs, PFMEAs, and risk-benefit analyses.
• Skills in combination products, component design and engineering, controls assurance, design analysis and evaluations, design controls, DFMEA, design verification and testing, device design, engineering leadership and specifications, equipment engineering and procurement, human factors engineering, mechanical engineering and testing, medical device quality systems, packaging management, process development engineering, QMS, test method validation, and troubleshooting.

Nice To Haves

• Prior experience serving as the dedicated Device Technical Lead (DTL) or Device Sub-Team Lead on combination product programs.
• Direct experience authoring and defending device constituent sections of BLA, NDA, or IND submissions and addressing formal health authority information requests.
• Hands-on experience directing external device OEMs, custom equipment automation integrators, and secondary packaging or assembly CDMOs.
• Extensive experience with bench-top device functional testing and data analysis, and designing and facilitating in-clinic device usability studies.
• Experience developing and/or characterizing autoinjectors, prefilled syringes (PFS), on-body injection systems, and/or near-body injection systems.

Responsibilities

• Chair and lead Device Development Sub-Teams, establishing technical roadmaps, integrated schedules, and resource allocation across internal specialists and external partners.
• Serve as the device design accountable leader at working-group level, aligning device milestones with clinical supply timelines, formulation characteristics, filling operations, and regulatory submission targets.
• Lead formal technical stage-gate reviews, including Concept Selection, Design Freeze, Design Verification Readiness, and Design Transfer Approval; build consensus and resolve technical trade-offs involving form, fit, function, manufacturability, cost, and schedule.
• Own the strategy, compilation, and maintenance of audit-ready Design History Files (DHF) aligned with applicable regulations and standards.
• Oversee the technical architecture of design verification and validation (DV&V) programs, including test methods, sample sizes, statistically based acceptance criteria, and Gauge R&R validations.
• Lead product-level risk analyses, including cross-functional Hazard Analyses, Design FMEAs, and Process FMEAs.
• Review and approve engineering specifications and component drawings, holding internal and external contributors to rigorous engineering standards.
• Manage technical deliverables from device OEMs and primary container suppliers; assess supplier and component manufacturing processes against combination product specifications, Critical Quality Attributes, and Critical to Function dimensions.
• Collaborate with internal and external stakeholders to develop a comprehensive control strategy.
• Author, review, and defend device constituent sections of global regulatory filings, including IND, IMPD, BLA Module 3.2.P.7, NDA, and MAA submissions.
• Develop technical responses to health authority information requests and deficiency letters, and serve as the primary device subject matter expert during Pre-Approval Inspections and notified body audits.
• Mentor and develop early-to-mid-career engineers (R1–R3), promoting technical excellence, root-cause problem solving, and cross-functional leadership.
• Lead continuous improvement initiatives across DD&T, including standardization of design control templates, sub-team governance frameworks, and technical best practices.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and families
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days
• Eligible for annual bonus and long-term incentive, if applicable
• Domestic relocation

What This Job Offers

• Job Type: Full-time
• Career Level: Senior