Senior Post-Market Quality Engineer
Company: Anteris Tech
Location: Osseo
Posted on: February 16, 2026
|
|
|
Job Description:
Job Description Job Description Salary: $110 - $130k 10% 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 worlds 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 Bachelors 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 Currently, Anteris is unable to
sponsor or transfer employment visas for this position. 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. Wehave 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. By applying to this position, you consent to
receive text messages from the Anteris Talent Acquisition team
regarding your application. Message and data rates may apply. You
may opt out at any time by replying STOP.
Keywords: Anteris Tech, Bloomington , Senior Post-Market Quality Engineer, Engineering , Osseo, Minnesota