Associate Principal Engineer, Drug-Device Combination Products

Job Description

This position is in our organization’s Device Development & Technology (DD&T) group in our Research division.  Our organization’s DD&T group is responsible for the development of devices, combination products, processes, testing and assembly equipment from conception through product launch. Products include autoinjectors, inhalers, implants, infusion pumps, vaginal rings and connected devices/apps. The person in this position contributes to high impact, complex, cross-functional, and cross-divisional teams, initiatives and will provide input to achieve project goals.  Effective collaboration with teams is essential to meet our company's goals/objectives.  The group also plays a key role in supporting commercially launched products.  

The DD&T organization is seeking an accomplished technical leader for the role of Associate Principal Engineer (R4). In this high-impact position, you will direct cross-functional engineering teams in the execution and delivery of complex combination product development programs.

While a deep foundational grounding in mechanical engineering, drug delivery systems, and manufacturing principles is required to provide rigorous technical scrutiny, the primary focus of this role is technical leadership, cross-functional team orchestration, and program delivery.

You will lead internal engineering teams (mechanical, systems, human factors, packaging, materials) and direct external partners (device OEMs, tooling/molding vendors, and CDMOs). You will represent the device constituent part at the integrated Development team, ensuring program milestones, design verification, manufacturing readiness, and regulatory compliance are achieved seamlessly.

Key Responsibilities:

1. Device Sub-Team Leadership & CMC Integration

• Chair and Lead Device Development Sub-Teams (DST): Establish technical roadmaps, integrated schedules, and resource allocation across internal technical specialists and external development partners.
• Act as the single-point device design accountable leader on working group levels, ensuring device milestones are tightly coupled with clinical supply timelines, formulation characteristics, filling operations, and regulatory submission targets.
• Lead formal technical stage-gate reviews (Concept Selection, Design Freeze, Design Verification Readiness, and Design Transfer Approval), driving consensus and resolving complex technical trade-offs between form, fit, function, manufacturability, cost, and schedule.

2. Design Controls, Risk Management & Technical Oversight

• Own the strategy, compilation, and maintenance of complete, audit-ready DHFs in full alignment with 21 CFR Part 4, 21 CFR 820.30, and ISO 13485.
• Oversee the technical architecture of DV&V programs, ensuring test methods, sample sizes, statistically based acceptance criteria, and Gauge R&R validations satisfy global regulatory expectations.
• Lead team through product-level risk analyses per ISO 14971, facilitating cross-functional Hazard Analyses, Design FMEAs, and Process FMEAs to ensure robust, patient-centric device functionality.
• Review and approve detailed engineering specifications, component drawings, holding internal and external contributors to first-principles engineering rigor.

3. Supplier, OEM & Commercial Assembly Line Readiness

• Manage day-to-day technical deliverables from device OEMs, and primary container suppliers.
• Interrogate device 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 build a comprehensive control strategy.

4. Regulatory Strategy & Health Authority Submissions

• Author, review, and defend the device constituent sections of global regulatory filings (e.g., IND, IMPD, BLA Module 3.2.P.7, NDA, MAA).
• Formulate technical responses to information requests (IRs) and deficiency letters from health authorities (FDA, EMA, PMDA) and serve as the primary device subject matter expert (SME) during Pre-Approval Inspections (PAIs) and notified body audits.

5. Talent Mentorship & Capability Building

• Mentor, guide, and develop early-to-mid career engineers (R1–R3), fostering an organizational culture rooted in technical excellence, disciplined root-cause problem solving, and cross-functional leadership.
• Champion continuous improvement initiatives across DD&T, standardizing design control templates, sub-team governance frameworks, and technical best practices.

Education Minimum Requirements:

• Bachelor of Science (BS) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or related engineering discipline with 8+ years of progressive regulated industry experience in medical device or combination product development; OR
• Master of Science (MS) in a relevant engineering discipline with 6+ years of relevant experience; OR
• Ph.D. in a relevant engineering discipline with 4+ years of relevant experience.

Required Experience and Skills:

• Demonstrated Technical Team Leadership: Proven experience leading cross-functional engineering teams or sub-teams in a matrixed pharmaceutical, biotechnology, or medical device development environment.
• Combination Product Design Controls: Comprehensive mastery of combination product regulations and design control standards, including 21 CFR Part 4, 21 CFR 820.30, ISO 13485, and ISO 14971.
• Program Delivery & Stakeholder Communication: Exceptional track record of managing complex technical milestones, balancing interdisciplinary priorities, and translating technical risks into clear, executive-level summaries for senior leadership and partner groups.
• Technical Evaluation & Critical Review: Strong mechanical aptitude, statistical analysis and first-principles engineering depth (tolerance stack analysis, material compatibility, and mechanical testing) to critically review, approve, and challenge technical work packages.
• Risk Management Expertise: Proven expertise facilitating and authoring system/device DFMEAs, PFMEAs, and risk-benefit analyses.

Preferred Experience and Skills:

• Prior direct experience serving as the dedicated Device Technical Lead (DTL) / Device Sub-Team Lead on combination product programs.
• Direct experience authoring and defending device constituent sections of BLA, NDA or IND submissions, as well as addressing formal Health Authority Information Requests.
• Hands-on experience directing external device OEMs, custom equipment automation integrators, and secondary packaging/assembly CDMOs.
• Extensive experience in bench-top device functional testing and data analysis and designing and facilitating in clinic device usability studies.
• Experienced in development and/or characterization of autoinjectors, PFS, on-body and/or near body injection systems.

Required Skills:

Combination Products, Component Design, Component Engineering, Controls Assurance, Design Analysis, Design Controls, Design Evaluations, Design Failure Mode and Effect Analysis (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, Troubleshooting

Preferred Skills:

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US and Puerto Rico Residents Only:

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The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/31/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.