Device Design Engineer Job at SII Group USA, Boston, MA

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  • SII Group USA
  • Boston, MA

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.

Job Tags

Full time,

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