Associate Principal Engineer, Drug-Device Combination Products

MSD • Rahway, NJ

1d • $142,400 - $224,100 • Hybrid

About The Position

The Associate Principal Engineer is part of the Device Development & Technology (DD&T) group in 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 and apps.

The role is a technical leadership position directing cross-functional engineering teams to deliver complex combination product development programs. It requires a strong foundation in mechanical engineering, drug delivery systems, and manufacturing principles, with a primary focus on technical leadership, team orchestration, and program delivery. The engineer leads internal specialists in mechanical engineering, systems, human factors, packaging, and materials, and directs external partners such as device OEMs, tooling and molding vendors, and CDMOs. The role represents the device constituent part on the integrated Development team and is accountable for program milestones, design verification, manufacturing readiness, and regulatory compliance.

Requirements

• Bachelor of Science in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or a related engineering discipline, with at least 8 years of progressive regulated-industry experience in medical device or combination product development; or a relevant Master of Science with at least 6 years of relevant experience; or a relevant Ph.D. with at least 4 years of relevant experience.
• Demonstrated experience leading cross-functional engineering teams or sub-teams in a matrixed pharmaceutical, biotechnology, or medical device development environment.
• Comprehensive mastery of combination product regulations and design control standards, including 21 CFR Part 4, 21 CFR 820.30, ISO 13485, and ISO 14971.
• A strong track record managing complex technical milestones, balancing interdisciplinary priorities, and communicating technical risks in clear executive-level summaries.
• Mechanical aptitude and depth in statistical analysis and first-principles engineering, including tolerance stack analysis, material compatibility, and mechanical testing.
• Proven expertise facilitating and authoring system/device DFMEAs, PFMEAs, and risk-benefit analyses.

Nice To Haves

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

Responsibilities

• Establish technical roadmaps, integrated schedules, and resource allocation across internal technical specialists and external development partners.
• Lead Device Development Sub-Teams and serve as the accountable device design 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, 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 (DHFs) aligned with applicable regulations and standards.
• Oversee the technical architecture of design verification and validation programs, including test methods, sample sizes, statistically based acceptance criteria, and Gauge R&R validations.
• Lead cross-functional product risk analyses under ISO 14971, including Hazard Analyses, Design FMEAs, and Process FMEAs.
• Review and approve engineering specifications and component drawings, ensuring rigorous first-principles engineering.
• Manage day-to-day technical deliverables from device OEMs and primary container suppliers.
• Evaluate supplier and component manufacturing processes against combination product process specifications, Critical Quality Attributes (CQAs), and Critical to Function (CTF) 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, fostering technical excellence, disciplined root-cause problem solving, and cross-functional leadership.
• Champion continuous improvement 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 family
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate days
• Sick days
• Eligible for an annual bonus and long-term incentive, if applicable

What This Job Offers

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