Design Quality Assurance Engineer II - Urology

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. Minimum of a Bachelor's Degree in mechanical, electrical, or biomedical engineering (or other related technical discipline). Minimum of 2 years of related experience. Travel approximately <10% Experience in the Medical Device industry (quality and risk management) and medical electrical systems. Detailed understanding of ISO 13485, ISO 14971, and Quality System Regulations. Skillful problem solver, capable of facilitating the problem-solving process and driving to solutions in a timely manner. Ability to work in a fast paced, dynamic environment while promoting / fostering cross-functional teamwork. Strong communication skills (verbal & written)