Principal 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.

The
Principal Process Development Engineer is a senior technical leader within the Manufacturing Development and Support team. This role partners closely with Quality Assurance, R&D/Product Development, and Manufacturing to develop, characterize, validate, and scale critical processes supporting Anteris Technologies’ transcatheter heart valve platform.

This position requires deep expertise in catheter-based device manufacturing and process validation, with responsibility for advancing manufacturing readiness from development through commercialization. The Principal Process Development Engineer will lead complex validation activities, drive process capability improvements, and serve as a technical mentor to junior engineers. This role plays a central part in ensuring the reliability, scalability, and performance of manufacturing processes supporting Anteris Technologies’ structural heart innovations.

At Anteris® Technologies, you’ll join a team committed to improving the lives of patients with aortic stenosis through groundbreaking structural heart solutions. This is an opportunity to make a measurable impact on patient outcomes while shaping the future of heart valve innovation.

Primary Duties and Responsibilities

Process Development and Optimization

• Lead the development, characterization, and optimization of manufacturing processes for Class III catheter-based medical devices.
• Translate design intent into scalable, robust manufacturing processes capable of supporting clinical and commercial production.
• Conduct feasibility studies and pilot programs for new process technologies and manufacturing approaches.
• Drive process characterization activities supporting transition to validated production processes.
• Implement mistake-proofing strategies and process improvements to reduce variability and human error in assembly operations.
• Identify opportunities for mechanization and automation of catheter assembly processes to improve efficiency and scalability.

Process Validation

• Lead the development and execution of comprehensive validation strategies including pFMEA, process characterization, and validation studies.
• Develop and execute protocols including IQ, IMV/TMV, OQ, and PQ/PPQ.
• Author and review validation protocols, technical reports, and study documentation.
• Contribute to development and execution of Master Validation Plans.
• Ensure validation activities meet cGMP requirements, regulatory standards, and internal quality system procedures.

Manufacturing & Continuous Improvement

• Support the transfer of processes from R&D to Manufacturing with focus on yield, throughput, and reproducibility.
• Drive root cause investigations and corrective/preventative actions for process deviations or performance issues.
• Lead initiatives to improve manufacturing efficiency, product quality, and cost structure.
• Develop and…