Senior Mechanical Engineer - Drug-Device Combination

Senior Mechanical Design Engineer – Drug-Device Combination Products

📍 Boston, MA (Hybrid) | 💼 Full-time | 🏥 Medical Devices / Pharma

About the Role

We are seeking a Senior Mechanical Design Engineer to join our growing R&D team. In this role, you will play a key part in the design, development, and validation of innovative drug–device combination products . This position is highly cross-functional, interfacing with R&D, Quality, Regulatory, Manufacturing, and Clinical teams to bring novel therapies from concept through commercialization.

The ideal candidate is a hands-on product development engineer with strong expertise in requirements engineering, design controls, and testing for FDA-regulated devices. Process development and manufacturing knowledge are a plus, but the core responsibility will be product design engineering .

Key Responsibilities

• Lead mechanical design and development of drug–device combination products from concept through design transfer.
• Translate user needs and voice-of-customer into engineering requirements and robust product specifications.
• Develop and maintain design history files (DHF) , design inputs / outputs, traceability matrices, and risk management documentation in compliance with ISO 13485, ISO 14971, and FDA QSR .
• Plan and execute verification and validation (V&V) activities, including test method development, protocol authoring, execution, and reporting.
• Perform and review tolerance stack-up analyses, GD&T, and CAD modeling (Creo / SolidWorks) .
• Collaborate with internal and external stakeholders (suppliers, CMOs, CROs) to ensure product design meets functional, quality, and regulatory requirements.
• Contribute to regulatory submissions (IND, NDA, BLA, 510k, PMA) by authoring or reviewing device design sections.
• Support root cause investigations, CAPAs, and continuous design improvements.
• Mentor junior engineers and contribute to a culture of collaboration and innovation.

Qualifications

Preferred Skills

What We Offer

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