Senior R&D Engineer at Haemonetics

You are an experienced engineer with over five years in the medical device industry who holds a bachelor’s degree in a technical field like biomedical or mechanical engineering. You have a background in managing product lifecycles and navigating regulatory audits for disposable medical products. **What makes it worth a look...** Haemonetics is hiring for this full-time, on-site role in Boston, MA. You will function as the primary design owner for apheresis and plasmapheresis products while leading critical sustaining engineering and CAPA investigations. **You might be a good fit if you...** * Have hands-on experience with FDA 21 CFR 820 design controls and DHF maintenance. * Can lead CAPA investigations and perform root cause analysis using structured methodologies. * Possess deep knowledge of ISO 13485 quality systems and ISO 14971 risk management. * Have navigated design change management processes and represented products during regulatory audits.