<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> <p>The Principal Process Development Engineer will be a key member of the Manufacturing Development and Support team, working cross-functionally with Quality Assurance, R&D/Product Development, and Production. This role is highly collaborative and technically demanding, with responsibility across several critical areas, including:</p> <ul> <li>Test method development and validation </li><li>Process and product characterization </li><li>Equipment validation, calibration, and requirements definition </li><li>Feasibility studies and pilot programs for new process technologies </li><li>Identification and implementation of new technologies to improve existing processes </li><li>Providing technical expertise, guidance, and mentorship to junior engineers </li></ul> <p>The Engineer will ensure all activities meet cGMP requirements and align with regulatory standards and site SOPs. This role has a strong emphasis on aortic valve design, production, performance, and characterization, making it central to Anteris Technologies' mission.</p> <p>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.</p> <p>Key Responsibilities:</p> <p>Validation</p> <ul> <li>Lead the transfer of processes from R&D to Manufacturing, with focus on scalability, yield, and throughput. </li><li>Drive robust process development and validation (pFMEA, process characterization, IMV / TMV, IQ / OQ / PQ / PPQ). </li><li>Develop and implement inspection methods (IMV/TMV) and assembly aids to improve yield and KPIs. </li></ul> <p>Calibration</p> <ul> <li>Support the site calibration program for critical equipment, instruments, and sensors. </li><li>Execute calibration and maintenance schedules. </li><li>Define calibration requirements for new equipment. </li><li>Prepare and maintain documentation, including procedures, calibration reports, certificates, and worksheets. </li></ul> <p>Manufacturing & Production</p> <ul> <li>Define and lead process development projects to strengthen production capabilities. </li><li>Promote a culture of quality, safety, and GMP compliance in the cleanroom. </li><li>Drive continuous improvement to enhance efficiency, reduce cost, and ensure product quality. </li><li>Develop, revise, and review manufacturing documentation. </li><li>Participate in audits and departmental meetings as required. </li><li>Lead troubleshooting, root cause analysis, and corrective/preventive action implementation. </li></ul> <p>Design & Development</p> <ul> <li>Partner with R&D, QA/QC, and Manufacturing in product and process development, validation, and risk analysis. </li><li>Support design verification testing for design control projects. </li><li>Use DOE and related studies to optimize valve components and assembly methods to improve hemodynamics. </li><li>Contribute to the design and development of new products and processes, with a focus on innovative heart valve manufacturing solutions. </li></ul> <p>Training</p> <ul> <li>Complete annual GMP training; serve as trainer for assigned responsibilities. </li><li>Ensure required training documentation is complete and current. </li><li>Support the design and execution of training activities. </li></ul> <p>Skills, Knowledge, Experience, Qualifications:</p> <p>Required Qualifications</p> <ul> <li>Bachelor of Science in Engineering or related field, with 10+ years of Process Development engineering experience. </li><li>Minimum 5 years' experience in Class III medical device development and validation. </li><li>Proven expertise in translating pFMEA and specifications into process development and validation strategies. </li><li>Proficiency in protocol development, execution, and reporting for IMV/TMV and IQ/OQ/PQ/PPQ. </li><li>Demonstrated success in continuous improvement initiatives (DOE, SPC, DMAIC, Six Sigma, Lean, KPI improvement). </li><li>Hands-on experience with catheter assembly processes, including multi-lumen steerable catheter assembly, braiding, adhesive joining, soldering, reflow, and balloon forming. (Experience in extrusion and laser welding is a plus.) </li><li>Strong interpersonal skills, with proven ability to collaborate with cross-functional teams, suppliers, and business partners. </li></ul> <p>Preferred Qualifications</p> <ul> <li>Advanced degree in Engineering or related discipline. </li><li>Experience leading and managing validation programs and projects. </li><li>Knowledge of statistics, quality systems, and regulatory requirements. </li><li>Experience with advanced process development, including jig/fixture/automation concepting and design. </li><li>Strong analytical and problem-solving skills, including root cause analysis. </li><li>Excellent technical writing and documentation skills. </li><li>Highly organized, detail-oriented, and proactive. </li><li>Strong verbal and written communication skills, with the ability to engage colleagues and stakeholders at all levels. </li></ul> <p>What We Offer:</p> <ul> <li>Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies. </li><li>Collaborative and dynamic work environment with a culture of innovation and excellence. </li><li>Competitive compensation package, including salary, performance-based bonuses, and stock options. </li><li>Career development opportunities and a chance to be part of a growing company that values its employees. </li></ul> <p>Health and Wellness Offerings:</p> <ul> <li>Medical, Dental, and Vision Offerings </li><li>Flexible Spending Account (FSA) </li><li>401k + Company Match </li><li>Life, AD&D, Short Term and Long-Term Disability Insurance </li><li>Bonus Plan Eligibility </li><li>Employee Equity Program </li><li>Paid Holidays & Vacation </li><li>Employee Assistance Program </li><li>Inclusive Team Environment </li></ul> <p>Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.</p> <p>Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.</p>