Senior Process Development Engineer - Delivery

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Additional Information

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. Lead risk management activities in accordance with ISO 14971 and FDA 21 CFR Part 820, including hazard analysis, failure mode assessment, and risk mitigation throughout the product lifecycle. Partner with cross-functional teams including R&D, Quality, and Manufacturing to ensure seamless integration of new processes into production environments. Conduct feasibility studies and pilot programs to evaluate and implement new process technologies and manufacturing methods. Catheter Manufacturing & Process Expertise Support development and optimization of processes related to catheter or sheath manufacturing, including assembly, adhesive joining, thermal bonding, and reflow processing. Implement mistake-proofing strategies (poka-yoke) and automation approaches to improve assembly reliability and reduce human error. Drive mechanization and automation initiatives to improve process consistency, throughput, and manufacturability of catheter-based devices. Jig Fixture Automation Design and implement automation solutions and jig fixtures to streamline manufacturing processes and reduce manual intervention. Oversee implementation of automated processes ensuring compliance with safety standards and regulatory requirements. Validation and Documentation Lead validation activities including IMV, TMV, IQ, OQ, and PPQ, including protocol development, execution, data analysis, and report generation. Develop robust validation strategies and technical documentation aligned with regulatory expectations. Prepare validation protocols, testing procedures, and validation reports demonstrating process capability and compliance. Create and maintain documentation including SOPs, work instructions, validation reports, and process flow documentation in accordance with GMP requirements. GMP Compliance Ensure manufacturing processes comply with Good Manufacturing Practices (GMP) and applicable global regulatory requirements. Partner with Quality Assurance to address compliance issues and implement corrective and preventive actions. Maintain strong adherence to ISO 13485 quality system requirements and related documentation practices. Cross-Functional Collaboration Provide manufacturing input during product de

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