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 or medical device 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.

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