Principal R&D Engineer
Core
Technical leader responsible for the design, development, verification, validation, commercialization, and lifecycle management of medical device products.
Role type
Principal R&D Engineer (Medical Devices)
Builds
Medical device products and 510k submissions
Domain
Healthcare / Medical Devices
Deliverable
production ML models | product features
Required skills
Medical device design controls, risk management, change management, design verification and validation, regulatory standards (FDA, ISO, IEC, EN), technical project management, CAD design, mechanical systems, plastics injection molding, component design
Preferred skills
Design for Six Sigma (DFSS), patent experience, Microsoft Project, manufacturing transfer
Technologies
SolidWorks, Microsoft Project
Responsibilities
Lead new product development, product enhancements, and sustaining engineering programs; Develop and execute design strategies incorporating regulatory standards; Provide technical leadership for Medical Device 510k submissions; Write and review technical specifications; Conduct technical and design reviews; Write protocols and reports for design verifications and validations; Conduct product level testing; Manage product transfer from R&D to manufacturing; Mentor engineering teams and drive continuous improvement.
Seniority
Principal, strategic leadership & hands-on IC