Research And Development Engineer
Current• Work within a team of Engineers & Clinicians to develop novel surgical solutions for traumatic and chronic conditions of the upper extremity.• Conduct and create design verification and validation protocols, test reports, and other design control documentation based on product specifications.• Manage all Elbow related projects including the design of new products and system improvements for existing products.• Develop regulatory strategies, 510(k), and assist in the creation of submission documentation.• Perform risk analysis (FMEA) of surgical methods, product design, and manufacturing processes.• Design, develop and validate test fixtures and inspection tools.• Determine inspection acceptance criteria based on desired risk profiles and confidence intervals based on Use & Design FMEAs.• Work closely with suppliers to incorporate DFM feedback into implant and instrument designs.• Assist outside counsel in the management of IP profile• Regularly travel to conferences and sales meeting to support the sales team with training and product information.