Quality Engineer II

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.

Anteris Technologies is seeking a Quality Engineer II to support the development, commercialization, and ongoing manufacturing of our delivery system. In this role, you will be a key contributor to ensuring manufacturing quality, process robustness, and regulatory compliance across our product platform. You will work cross-functionally with engineering, manufacturing, and quality teams to drive validation, risk management, and continuous improvement initiatives.

In this role, you will:

Partner with R&D, Design, Process, and Manufacturing Engineering to develop and execute product and process validation strategies.

Support delivery system manufacturing processes, including product quality activities.

Participate in cross-functional mRB discussions and support nonconformance invesigations, including CAPAs and customer complaints.

Develop sampling plans and approve inspection methods for in-process and finished product acceptance.

Review and support execution of validation activities including IQ, OQ, PQ, TMV, and software validation

Analyze product and process performance to identify failure modes, trends, and opportunities for improvement

Support resolution of complex technical issues related to manufacturing processes

Ensure compliance with applicable regulatory standards (e.g., FDA CFR 820, ISO 13485, ISO 14971) and support audit readiness and execution

Maintain and assess effectiveness of CAPAs and quality system processes

Contribute to risk management activities, including PFMEAs and process risk assessments

Develop and maintain process monitoring and control strategies aligned to product and process risk

Evaluate process variation and capability, driving continuous improvement initiatives where needed

Support development and maintenance of quality documentation, including control plans, work instructions, and inspection methods

Participate in internal and external audits and respond to audit observations as needed

Conduct manufacturing process audits to ensure adherence to GMP, production controls, and quality standards

Basic Qualifications:

Bachelor’s degree in Engineering, Physical Science, or related discipline

2+ years of manufacturing quality experience in a medical device company

Experience supporting process validation, risk management, nonconformance handling, and process improvement in regulated environments

Working knowledge of FDA CFR 820, ISO 13485, and ISO 14971

Understanding of process controls, statistics, test method validation, and new product development processes

Experience with product and process verification and validation activities

Strong technical writing and documentation skills

Preferred Qualifications:

Master’s degree in Engineering or related field

Experience with Class III medical devices

Experience with valve manufacturing or biological tissue products

Familiarity with ISO 5840 standards

Strong knowledge of inspection methods and measurement systems

Experience with statistical tools, DOE, and process capability analysis

Certifications such as ASQ CQE, Six Sigma, or CQA

Experience with requirements management tools (e.g., Jama Connect)

Demonstrated ability to solve complex problems and contribute in a fast-paced, cross-functional environment

Compensation:

Target base salary range: $88,000 – $108,000, plus eligibility for an annual short-term incentive (STI) targeted at 7% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

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.

Our 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 Equity Program

Paid Holidays

Paid Vacation

Employee Assistance Program

Inclusive Team Environment

This is the national market pay scale.

Salary Range $88,000 — $108,000 USD

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.