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.
KEY DUTIES AND RESPONSIBILITIES
- Serve as a product development engineer on cross-functional teams
- Developing and documenting manufacturing processes to support test article builds for verification and validation testing
- Managing 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 specifications
- Owning design history file content and updates throughout the product lifecycle, including supporting process changes/improvements
- Supporting process changes/improvements for other products not regulated as medical devices
- Supporting ideation and concept development by identifying/reviewing possible predicate devices, manufacturing considerations, and customer inputs
- Supporting design and development activities including defining design inputs and outputs, managing product risk assessment activities, creating and managing verification and validation test plans
- As needed, support laboratory testing or test article production
- Manage relationships with external testing or manufacturing vendors, and/or other suppliers
EDUCATION/CERTIFICATION
- Master’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 SKILLS
- Proficiency and working experience in design controls for medical device development
- Experience 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 management
- Demonstrated 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 procedures
- Excellent problem-solving and analytical skills and attention to detail
- Excellent 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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