Senior Post-Market Quality Engineer

Join to apply for the Senior Post-Market Quality Engineer role at Anteris Technologies 2 days ago Be among the first 25 applicants Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve. The Senior Post-Market Quality Engineer is a critical technical leader responsible for supporting and improving commercial and clinical-stage products throughout their lifecycle. This role ensures the ongoing performance, safety, and regulatory compliance of Anteris Technologies’ Class III medical devices. The engineer will partner closely with cross-functional teams across Quality, Manufacturing, Regulatory, R&D, and Clinical to lead investigations, manage post-market feedback, and drive continuous product improvement. At Anteris® Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions. Key Responsibilities Lead post-market quality activities, including complaint investigations, returned product analysis, and trending of customer feedback Ensure compliance with FDA, ISO 13485, EU MDR, and other global regulations governing Class III implantable devices Serve as a subject-matter expert for complaint investigations, root cause analysis, and CAPA execution Collaborate with Clinical Affairs, Quality, Manufacturing, Regulatory, and R&D to assess and act on post-market insights Develop and present complaint trends, risk assessments, and other reports for regulatory bodies and senior leadership Skills, Knowledge, Experience, Qualifications Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical field Minimum of 5 years of Quality Engineering experience, including 2+ years focused on complaint handling in the medical device industry Experience with Class III devices and catheter-based therapies strongly preferred Deep understanding of FDA 21 CFR Part 820, ISO 13485, EU MDR, and associated quality and regulatory requirements Strong knowledge of root cause analysis and risk management (ISO 14971) Proven ability to collaborate in a cross-functional environment and drive outcomes Excellent communication and project management skills, with demonstrated success operating in a fast-paced, regulated environment What We Offer Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies. Collaborative and dynamic work environment with a culture of innovation and excellence. Competitive compensation package, including salary, performance-based bonuses, and stock options. Career development opportunities and a chance to be part of a growing company that values its employees. Health and Wellness Offerings Medical, Dental, and Vision Offerings Flexible Spending Account (FSA) 401k + Company Match Life, AD&D, Short Term and Long-Term Disability Insurance Bonus Plan Eligibility Employee Stock Option Plan Paid Holidays & Vacation Employee Assistance Program Inclusive Team Environment Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations. Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale. Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industry: Medical Equipment Manufacturing #J-18808-Ljbffr