Process Development Engineer

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.

We are seeking a Senior Process Development Engineer who will be a key member of the Manufacturing Development and Support team, partnering closely with Management, Quality Assurance, R&D/Product Development, and Production. This is a technically deep and multi-faceted role responsible for developing, validating, and optimizing manufacturing processes supporting Class III structural heart devices.

The Engineer will contribute across several critical areas including process and product characterization, test method development and validation, equipment validation and calibration requirements, feasibility studies for new process technologies, and the implementation of improved manufacturing methodologies. This individual will execute all activities in accordance with cGMP requirements, regulatory expectations, and site SOPs to ensure processes are robust, compliant, and scalable. The role has a strong emphasis on biological tissue processing, device production, performance characterization, and process reliability.

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.

Primary Duties and Responsibilities

Process Development and Optimization

• Develop and optimize manufacturing processes for medical devices, with focus on performance, quality, scalability, and efficiency.
• Lead process characterization activities and transition processes through OQ readiness and commercialization.
• Drive continuous improvement initiatives to enhance product quality, reduce manufacturing cost, and increase manufacturing throughput.
• Apply structured problem-solving methodologies such as 5 Whys, Fishbone, and statistical analysis to resolve process issues.