Anteris Technologies

Senior Process Development Engineer

Maple Grove, Minnesota, United States · Senior

No sponsorship$118k-$138kDetected 20 days ago

Supply ChainCustomer SupportFDA RegulatoryMedical DevicesProblem Solving

About the role

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.
Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function.

3+ years' experience with a graduate degree.
Experience with design transfer from development into regulated production.
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and EU MDR expectations.
Hands-on experience with fixture design, process automation, and equipment qualification.
Ability to use microscopes and other magnification equipment

Degrees in Engineering or Chemical Engineering and/or an advanced degree (MS) in Engineering or related field desired.
Direct experience with catheter-based or structural heart devices strongly preferred.
Experience with transcatheter heart valves (TAVR, TMVR, TPV) or delivery systems.
Experience working in a pre-commercial or scaling organization.
Knowledge of ISO 5840-1/ -3.
Final compensation will be based on experience and alignment with role requirements.

Plan and execute development and optimization of manufacturing processes for Class III transcatheter heart valves.
Provide DFM/DFA input during product development to ensure manufacturability and cost efficiency.
Improve repeatability and reduce operator variability through fixture optimization and automation strategies.
Improve and establish visual inspection methods for tissue and valve manufacturing, ensuring repeatability and reproducibility.
Plan and execute product performance and functional assessments associated with process changes and improvements.
Drive design transfer activities from R&D to Manufacturing.

Target base salary range: $118,000 - $138,000, plus annual incentive opportunity and equity eligibility.
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.
$118,000 - $138,000 USD
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:

Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
Competitive compensation package, including salary, performance-based bonuses, and stock options.
Health and Wellness Offerings:
Medical, Dental, and Vision Plans
Flexible Spending Account (FSA)
Life, AD&D, Short Term and Long-Term Disability Insurance
Bonus Plan Eligibility
Employee Equity Program
Paid Holidays & Vacation

Career development opportunities and a chance to be part of a growing company that values its employees.

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.