About

• Minimum Bachelor's degree, in Mechanical or Biomedical Engineering preferred 5+ years of relevant experience in a regulated medical device environment 4+ years of hands-on experience with design controls Experience with Ultrasound medical systems and transducer design and analysis is highly preferred Proven expertise in product development lifecycle, including design, testing, and risk analysis Experience with ultrasound imaging catheters and systems Knowledge of medical device regulations and standards: ISO 13485, ISO 14971, 21 CFR Part 820, ISO 11135, and ISO 11607 Experience in rapid design iteration, technical troubleshooting, and process improvement Strong statistical analysis skills and familiarity with DOE Demonstrated ability to work independently and lead within multidisciplinary teams Excellent verbal and written communication skills Strong interest in biomedical innovation and product performance improvement Ability to work in a high-paced, collaborative environment with shifting priorities Experience with leading more junior engineers