Your responsibilities will include: Support Usability Engineering and planning documentation (i.e., EN / ISO 62366 and IEC 606061-1-6). Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues in a timely manner. Supporting post market activities ensuring our products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals. Support internal and external regulatory audits as required.