The R&D Engineer II/III, Medical Device will be responsible for supporting the development of novel biomaterial products in the medical device field, with an emphasis on process development and design transfer. A key responsibility will be driving design control activities during these phases with the goal of creating and maintaining an organized and compliant design history file to support device lifecycle. The R&D Engineer II/III will also support project management and may contribute to hands-on testing and other aspects of product development.
\n KEY DUTIES AND RESPONSIBILITIESServe as a product development engineer on cross-functional teamsDeveloping and documenting manufacturing processes to support test article builds for verification and validation testingManaging design transfer to production including coordination with cross-functional teams and/or external manufacturing partners, managing scaleup and transfer to production, finalizing material and product specificationsOwning design history file content and updates throughout the product lifecycle, including supporting process changes/improvementsSupporting process changes/improvements for other products not regulated as medical devicesSupporting ideation and concept development by identifying/reviewing possible predicate devices, manufacturing considerations, and customer inputsSupporting design and development activities including defining design inputs and outputs, managing product risk assessment activities, creating and managing verification and validation test plansAs needed, support laboratory testing or test article production Manage relationships with external testing or manufacturing vendors, and/or other suppliers EDUCATION/CERTIFICATIONMaster's degree in Biomedical Engineering/Bioengineering/Chemical/ Engineering with two (2) to three (3) years of relevant work experience in medical device or similar industry; or Bachelor's degree with three (3) to five (5) years of relevant work experience in industry. REQUIRED KNOWLEDGE AND SKILLSProficiency and working experience in design controls for medical device developmentExperience in developing, scaling, and/or implementing manufacturing processes for biological materials, including collaboration with external contract manufacturers or internal manufacturing teams.Knowledge of engineering principles including specification development, material selection, and risk managementDemonstrated project management skills such as ability to create project schedules and manage project timelines in cross functional team setting. Strong understanding of regulatory requirements for medical device development and quality management systems (e.g., ISO 13485)Excellent technical writing skills, including an ability to create manufacturing proceduresExcellent problem-solving and analytical skills and attention to detailExcellent communication skills, including an ability to establish and maintain effective working relationships. Working knowledge of product performance testing (biological wet lab)Experience with technical drawings and 3D CAD modeling preferred
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