Product Development Engineer

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. About the Organization We are a dedicated and multidisciplinary group of problem solvers with decades of engineering expertise. As a leader in complex catheter development we have assembled a team of world class engineers that don't shy away from challenges. Position Product Development Engineer Description The Product Development Engineer I supports product development activities from concept through commercialization, executing design controls, testing, risk management, and documentation in compliance with QMSR, ISO 13485:2016, and ISO 14971. Duties and Responsibilities Support design transfer activities including DFM/DFA input, pilot builds, process development, and required documentation. Develop and validate test methods; design simple fixtures to enable repeatable testing. Maintain requirements traceability and contribute to formal design reviews. Execute verification protocols, analyze data, and generate compliant reports. Perform feasibility studies, product characterization, and risk analysis. Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and suppliers. Participate in customer meetings and present technical updates as needed. Maintain accurate engineering documentation throughout all development phases. Position Requirements Qualifications Bachelor’s degree in Mechanical or Biomedical Engineering (or related field). 0–3 years of experience in medical device design under design controls. Working knowledge of 21 CFR 820/QMSR, ISO 13485:2016, and ISO 14971. Proficiency in SolidWorks; experience with GD&T and tolerance stack-ups. Hands-on prototyping, testing, fixture development, and measurement skills. Experience with Minitab for statistics, DOE, and gage R&R. Preferred: Experience with catheter technologies and relevant anatomy. Compensation & Benefits Salary Range: $75,000–$90,000 Flexible Time Off; 9 Paid Holidays Health, Dental, and Vision coverage Short- & Long-Term Disability options HSA with employer contribution 401(k) with employer contribution Exempt/Non-Exempt Exempt Full-Time/Part-Time Full-Time Open Date 8/26/2026 This position is currently accepting applications. #J-18808-Ljbffr