Senior R&D Engineer

Bachelor's degree in biomedical engineering, mechanical engineering, electrical engineering, systems engineering, or a related field. 5+ years of relevant experience in a regulated medical device environment Proven expertise in product development lifecycle, including design, testing, and risk analysis Knowledge of design requirements as per ISO 13485 and other relevant regulatory standards. Experience leading rapid design iterations and making informed design recommendations based on systems-level analysis. Strong hypothesis-driven experimental design and statistical analysis skills to assess system performance. Ability to work both independently and collaboratively within a diverse group of engineers and production staff. Excellent organizational, communication, and collaboration skills, with the ability to contribute effectively to team objectives. Related experience in the development of Medical Electrical Systems in the medical device industry Experience with IEC 60601-1 and collateral standards Experience with IEC 62304 Experience with Medical Device Cybersecurity Experience with leading more junior engineers