Manufacturing Engineer, Medical Device Industry

Device Design Engineer – Drug-Device Combination Products&##128205;Boston, MA&##128188;Full-time | On-siteAbout the RoleSII Group USA is seeking aDevice Design Engineeron 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 ResponsibilitiesLead 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.UtilizeCreo software suitefor product design and development.Contribute to project management activities, including planning, tracking, and reporting.Ideal Candidate ProfileBachelor’s or Master’s degree inMechanical, Plastics, or Medical Engineering(or related field).Proven experience indrug–device combination product or medical device development, industrialization, or manufacturing.Proficiency with theCreo software suite.Strong knowledge ofproduct lifecycle management.Demonstrated track record leading development projects and managing interdisciplinary teams.Familiarity withregulatory 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.

Created: 2025-09-26