Contraline is a medical device company based in Charlottesville, Virginia. We are developing the first long-lasting, non-hormonal, and reversible male contraceptive. Our mission is to improve the reproductive health of patients worldwide by commercializing state-of-the-art medical products.

The Product Engineer II/III participates as an R&D team member in the development of current and new medical devices, as well as the transfer of products into production settings. This position will report directly to the Chief Technology Officer.

• Develop tests and protocols or modify existing test/methods/protocols as needed by the quality and regulatory system • Participate in the developing initial manufacturing processes and documentation in concert with Manufacturing Engineering and Quality Engineering. • Perform design validation/verification and generate reports. • Generate and ensure completeness of all product build documentation prior to manufacturing transfer. If needed, provide assembler training to support transfer. • Generate and maintain proper documentation to support product development, i.e. drawings, specifications, lab notebook entries, design verification test protocols/reports and test methods. • Participate in FMEA analyses. • Provide input to Regulatory Affairs to fulfill requirements for submissions. • Perform other duties and projects as requested.

• BS/MS degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related engineering discipline. • Minimum of 2 years in product development of medical devices and/or as an R&D Engineer. • Knowledge of injectables, polymers, material science and/or polymer science. • Familiarity with design for manufacturability is desired • Ability to interact with suppliers and contractors in a professional manner • Proven experience working together on teams and meeting project deadlines • SolidWorks 3D CAD proficiency • Familiarity with FDA QSR and ISO 13485 medical device regulations • Familiarity with probability and statistics • Excellence in communication, writing, and presentations • Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit