Senior Mechanical Engineer - Drug-Device Combination
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 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
- Bachelor’s or Master’s in Mechanical, Biomedical, or related Engineering field (PhD a plus).
- 5+ years of hands-on experience in medical device or drug–device 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.