Anteris Technologies

Principal Sustaining Engineer

Brooklyn Park, MN · Principal · Contract

No sponsorship$60k-$80kDetected 22 days ago

ComplianceProject ManagementSolidWorksMechanical DesignFDA RegulatoryMedical DevicesCommunicationProblem Solving

About the role

With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Lead sustaining engineering activities, including design modifications, process improvements, and component/material changes, ensuring product quality and reliability.
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.
Stay updated on industry trends, emerging technologies, and regulatory changes to drive continuous improvement initiatives.
Strong knowledge of risk management (ISO 14971), design control, and verification/validation processes.
Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.

Proficiency in engineering tools such as CAD (SolidWorks), FMEA, and statistical analysis.

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
Master's degree preferred.

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care.
Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function.

Target base salary range: $60 - $80 /hr.
Final compensation will be based on experience and alignment with role requirements.
Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.
Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.
What We Offer:
Collaborative and dynamic work environment with a culture of innovation and excellence.

Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.
Ensure compliance with medical device regulations (FDA, ISO 13485, MDR) and contribute to audits and regulatory submissions as needed.
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.

Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.
The chance to be part of a growing company that values its people.

Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

This listing is sourced directly from Anteris Technologies's careers page and normalized into a canonical job model.