Principal Sustaining Engineer

Anteris Technologies • Brooklyn Park, MN

1d • $60 - $80

About The Position

The Principal Sustaining Engineer is a highly skilled and experienced technical leader responsible for supporting and improving existing products throughout their lifecycle. This contract role is pivotal in ensuring the continued performance, safety, and regulatory compliance of Anteris Technologies’ medical devices. The engineer will work cross-functionally with Quality, Manufacturing, Regulatory, Quality and other teams to drive product improvements, cost reductions, and design optimizations.

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.

Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• Minimum of 10 years of experience in R&D, sustaining engineering, or product development within the medical device industry.
• Deep understanding of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and EU MDR.
• Strong knowledge of risk management (ISO 14971), design control, and verification/validation processes.
• Proficiency in engineering tools such as CAD (SolidWorks), FMEA, and statistical analysis.
• Experience working in a cross-functional environment and leading product improvement initiatives.
• Strong analytical and problem-solving skills, with a hands-on approach to technical challenges.
• Excellent communication and project management skills, with the ability to work in a fast-paced, regulated environment.

Nice To Haves

• Master’s degree preferred.

Responsibilities

• Lead sustaining engineering activities, including design modifications, process improvements, and component/material changes, ensuring product quality and reliability.
• Provide technical expertise to resolve product performance issues, field complaints, and non-conformances.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for product issues.
• Collaborate with cross-functional teams to assess and implement design changes, ensuring compliance with regulatory requirements.
• Support manufacturing teams, both internal and contract manufacturing, in troubleshooting production issues and optimizing processes.
• Evaluate and qualify alternate materials, suppliers, and manufacturing processes to ensure continuity of supply and cost-effectiveness.
• Prepare and review technical documentation, including engineering change orders (ECOs), risk assessments, test protocols, and validation reports.
• Ensure compliance with medical device regulations (FDA, ISO 13485, MDR) and contribute to audits and regulatory submissions as needed.
• Mentor junior engineers and contribute to knowledge sharing within the R&D team.
• Stay updated on industry trends, emerging technologies, and regulatory changes to drive continuous improvement initiatives.

Benefits

• 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.
• The chance to be part of a growing company that values its people.

What This Job Offers

• Career Level: Principal