Job Description

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 drugdevice 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 drugdevice 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

• Bachelors or Masters in Mechanical, Biomedical, or related Engineering field (PhD a plus).
• 5+ years of hands-on experience in medical device or drugdevice combination product development .
• Proven expertise with design controls, requirements engineering, and risk management in regulated environments.
• Strong background in verification & validation (V&V), test method development, and statistical analysis (DOE, Minitab, JMP) .
• Proficiency in CAD tools (Creo prefered, SolidWorks) and application of GD&T and tolerance analysis .
• Knowledge of ISO 13485, ISO 14971, FDA QSR, EMA, and EU MDR regulations.
• Experience collaborating cross-functionally with Quality, Regulatory, Manufacturing, and Clinical teams .
• Excellent problem-solving, communication, and documentation skills .

Preferred Skills

• Experience with drug delivery systems (e.g., injectors, inhalers, implantables).
• Exposure to plastics, injection molding, electromechanical assemblies .
• Lean Six Sigma / Design for Six Sigma certification.
• Prior contribution to regulatory submissions .

What We Offer

• Opportunity to shape the future of life-changing combination products .
• Collaborative, mission-driven culture with exposure to cross-functional global teams .
• Competitive compensation and benefits package.
• Professional development and growth opportunities.

🔗 Apply Now on LinkedIn and be part of our mission to deliver innovative therapies to patients worldwide.

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