Associate Principal Engineer, Drug-Device Combination Products

Merck•Rahway, NJ

10h•$142,400 - $224,100•Hybrid

About The Position

The Associate Principal Engineer is a technical leader 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. Product areas include autoinjectors, inhalers, implants, infusion pumps, vaginal rings, and connected devices and apps. The role directs cross-functional engineering teams in delivering complex combination product development programs. It leads internal specialists across mechanical engineering, systems, human factors, packaging, and materials, and directs external partners such as device OEMs, tooling and molding vendors, and CDMOs. The position represents the device constituent part on integrated development teams and ensures program milestones, design verification, manufacturing readiness, and regulatory compliance are achieved. Its primary focus is technical leadership, cross-functional coordination, and program delivery, supported by strong grounding in mechanical engineering, drug delivery systems, and manufacturing principles.

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 engineering MS with at least 6 years of relevant experience; or a relevant engineering 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 knowledge of combination product regulations and design control standards, including 21 CFR Part 4, 21 CFR 820.30, ISO 13485, and ISO 14971.
Track record managing complex technical milestones, balancing interdisciplinary priorities, and translating technical risks into clear executive-level summaries for senior leaders and partner groups.
Mechanical aptitude, statistical analysis, and first-principles engineering depth, including tolerance stack analysis, material compatibility, and mechanical testing, to critically review and approve technical work packages.
Expertise facilitating and authoring system/device DFMEAs, PFMEAs, and risk-benefit analyses.
Required skills include Combination Products, Component Design, Component Engineering, Controls Assurance, Design Analysis, Design Controls, Design Evaluations, DFMEA, Design Verification, Design Verification Testing, Device Design, Engineering Leadership, Engineering Specifications, Equipment Engineering, Equipment Procurement, Human Factor Engineering, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems, Packaging Management, Process Development Engineering, Quality Management Systems (QMS), Test Method Validation, and Troubleshooting.

Nice To Haves

Prior experience 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 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 in 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

Establish technical roadmaps, integrated schedules, and resource allocation for Device Development Sub-Teams, internal specialists, and external development partners.
Serve as the accountable device design leader at working-group level, coordinating 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 (DHFs) aligned with 21 CFR Part 4, 21 CFR 820.30, and ISO 13485.
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 under ISO 14971, including cross-functional Hazard Analyses, Design FMEAs, and Process FMEAs.
Review and approve engineering specifications and component drawings, ensuring rigorous engineering review of internal and external contributions.
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 (R1–R3), promoting technical excellence, disciplined root-cause problem solving, and cross-functional leadership.
Lead continuous improvement across DD&T, including standardization of design control templates, sub-team governance frameworks, and technical best practices.