Anteris Technologies · 3 hours ago
Senior Post-Market Quality Engineer
Maple Grove, MN
Full-time
Onsite
Senior Level
5+ years expAnteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. The Senior Post-Market Quality Engineer is a critical technical leader responsible for supporting and improving commercial and clinical-stage products throughout their lifecycle, ensuring ongoing performance, safety, and regulatory compliance of Class III medical devices.
BiotechnologyHealth CareMedical
Hiring Manager
Erica Almgren Steffenson
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
Qualification
Required
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
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
Preferred
Experience with Class III devices and catheter-based therapies strongly preferred
Benefits
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
Company
Anteris Technologies
Anteris Technologies is a structural heart company focused on developing innovative & durable health solutions.
51-200 employees
H1B Sponsorship
Anteris Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
Funding
Current Stage
Public CompanyTotal Funding
$34.29MKey Investors
Partners for Growth
2023-02-09Post Ipo Equity· $24.29M
2017-10-01Post Ipo Debt· $10M
2004-03-24IPO
Leadership Team
Wayne Paterson
CEO and Managing Director
David St. Denis
Chief Operating Officer
Recent News
Anteris Technologies Pty Ltd
2025-11-18
Anteris Technologies Pty Ltd
2025-11-13
MarketScreener
2025-11-03
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