Anteris Technologies
Senior Post-Market Quality Engineer
Anteris Technologies, Osseo, Minnesota, United States, 55311
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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
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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
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