Senior Manufacturing Engineer

About this role

<div class="content-intro"><p>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.</p> <p>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.</p></div><p>We are seeking a<strong> Senior Manufacturing Engineer</strong> to provide technical leadership for <strong>delivery system manufacturing processes, </strong>supporting catheter-based systems for next-generation structural heart technologies. This role is responsible for ensuring that delivery system manufacturing operations are robust, scalable, validated and compliant as the organization advances toward clinical milestones and commercial readiness. This role will serve as the subject matter expert in catheter and delivery system manufacturing partnering closely with R&D, Quality, Regulatory, Supply Chain, Process Development, and Production. The role combines hands-on engineering support with process ownership, ensuring manufacturing processes meet the highest standards of quality, compliance, and operational performance.</p> <p>At Anteris Technologies, you’ll join a mission-driven team dedicated to improving the lives of patients with aortic stenosis through breakthrough structural heart technologies — and help build the organizational foundation supporting that impact.</p> <p><strong>Primary Duties and Responsibilities</strong></p> <p><strong>Delivery System Manufacturing Process Ownership</strong></p> <ul> <li>Establish and maintain the Device Master Record (DMR) for delivery system products including: specifications, BOM structures, manufacturing procedures, and production records.</li> <li>Define and control Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) for: <ul> <li>Catheter assembly and sub-assemblies</li> <li>Balloon forming and bonding</li> <li>Sheath assembly, adhesives, and leak testing</li> </ul> </li> <li>Conduct process capability analyses, GR&R studies, and statistical evaluations to ensure process robustness</li> <li>Lead efforts to scale delivery system manufacturing from clinical builds to commercial production</li> <li>Drive yield improvements, scrap reduction, and cycle time optimization</li> </ul> <p><strong>Process Validation & Compliance</strong></p> <ul> <li>Develop, execute, and maintain validation activities including: <ul> <li>Process, equipment, inspection, and test method validation (IQ/OQ/PQ/PPQ)</li> </ul> </li> <li>Own risk management documentation including PFMEA and control strategies</li> <li>Partner with Quality and Regulatory to ensure alignment with: <ul> <li>FDA Quality System Regulation (21 CFR 820)</li> <li>ISO 13485 and applicable global standards</li> </ul> </li> <li>Ensure validation packages and processes are inspection- and audit-ready</li> </ul> <p><strong>Manufacturing Support and Technical Leadership</strong></p> <ul> <li>Provide hands-on engineering support for catheter and delivery system manufacturing operations</li> <li>Troubleshoot process deviations, nonconformances, and CAPAs related to: <ul> <li>Assembly, bonding, balloon forming, and system integration</li> </ul> </li> <li>Lead engineering investigations for manufacturing and quality issues</li> <li>Own and drive change management activities for: <ul> <li>Process improvements</li> <li>Equipment updates</li> <li>Documentation revisions</li> </ul> </li> <li>Develop and continuously improve SOPs, work instructions, and batch records</li> </ul> <p><strong>Equipment and Manufacturing Infrastructure </strong></p> <ul> <li>Specify, procure, and qualify: <ul> <li>Delivery system manufacturing equipment, tooling, and fixtures</li> </ul> </li> <li>Define calibration and preventative maintenance strategies</li> <li>Design and optimize fixtures, tooling, and workstations to improve: <ul> <li>Repeatability</li> <li>Operator efficiency</li> <li>Ergonomics</li> </ul> </li> </ul> <p><strong>Cross-Functional and Regulatory Support      </strong></p> <ul> <li>Partner with R&D and Process Development during design transfer to ensure manufacturability</li> <li>Support internal and external audits, including FDA and notified body inspections</li> <li>Provide technical input to regulatory submissions and validation documentation</li> <li>Interface with suppliers of delivery system components and materials to ensure: <ul> <li>Quality</li> <li>Process…