Seeking an experienced R&D Engineer to help transition orthopedic sports medicine products into manufacturing. This position will manage engineering documentation, change activities, product verification, and transfer work while partnering with Quality, Regulatory, and Manufacturing teams.
Responsibilities
Own engineering deliverables related to product and manufacturing changes.
Prepare and manage CCPs and CCRs through completion.
Coordinate change activities across R&D, Quality, Regulatory, and Manufacturing.
Establish plans for product verification, validation, and stability.
Develop manufacturing transfer documentation and track required deliverables.
Maintain product requirements and traceability documentation.
Review process verification and validation results.
Manage engineering documents using Windchill or other PLM systems.
Assist with test protocols, reports, and technical documentation.
Participate in project meetings and provide engineering input.
Conduct and document short benchtop simulated-use tests when working onsite.
Requirements
Bachelor's degree in Engineering.
5+ years of R&D/product development experience within medical devices.
Experience with orthopedic or sports medicine products is preferred.