The R&D Engineer supports the development of medical device products, including writing or verifying specifications, maintaining product process, designing fixtures, test processes and equipment and raw materials to ensure concepts and/or prototypes meet requirements. This role involves technical responsibilities such as designing, developing, modifying, and verifying mechanical components for medical devices under supervision. It also includes assisting with prototyping, bench testing, and testing prototypes to verify they meet design requirements. The engineer will support problem-solving, root cause analysis, and the evaluation of potential solutions while maintaining traceability. Research and studies to support product design and process development, as well as the development of new test methods, fixtures, and inspection processes, will be part of the role. Additionally, the engineer will aid with specification development and testing of new materials and designs, ideate new design concepts, generate intellectual property, perform statistical analysis, and contribute to Design Reviews. Business responsibilities include understanding customer needs, design inputs, and the product's intended use. The role involves individual Design History File task ownership, including testing and drawings. In terms of Med Device Compliance, the engineer will understand industry standards, design requirements, and test strategies aligned with regulatory requirements. With supervision, they will create or refine engineering documentation, learn R&D procedures like design controls and risk management per the Quality Management System. General responsibilities include working with various departments (R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, Project Management) to ensure project success, learning procedures and systems, working on limited scope problems, demonstrating ownership and integrity, building stable relationships, and contributing to the project as a team member.
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Job Type
Full-time
Career Level
Intern
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees