Job Description
Device Design Engineer – Drug-Device Combination Products
📍 Boston, MA
💼 Full-time | On-site
About the Role
SII Group USA is seeking a Device Design Engineer on behalf of our client in the pharmaceutical/medical device industry. This role will support the development of innovative drug–device combination products, driving design from concept through industrialization while ensuring compliance with global regulatory standards.
Key Responsibilities
- Lead design and development activities for drug–device combination products.
- Drive projects through the full product lifecycle, from concept to launch.
- Manage interdisciplinary project teams and external partners.
- Ensure designs comply with relevant standards (DIN, ISO) and regulatory agency requirements (FDA, EMA, TUEV).
- Collaborate with manufacturing and quality teams to ensure design for manufacturability and robust industrialization.
- Utilize Creo software suite for product design and development.
- Contribute to project management activities, including planning, tracking, and reporting.
Ideal Candidate Profile
- Bachelor’s or Master’s degree in Mechanical, Plastics, or Medical Engineering (or related field).
- Proven experience in Drug Device Combination Product development, industrialization, or manufacturing.
- Proficiency with the Creo software suite.
- Strong knowledge of product lifecycle management.
- Demonstrated track record leading development projects and managing interdisciplinary teams.
- Familiarity with regulatory standards and agencies (FDA, EMA, TUEV, DIN, ISO).
- Project management experience (PMP certification or equivalent) is a plus.
Why Join?
- Opportunity to contribute to life-changing healthcare innovations.
- Collaborative environment working across engineering, manufacturing, and regulatory teams.
- Be part of a company shaping the future of drug–device solutions.