Manufacturing Engineer II at Anteris in Maple Grove, MN

Job description

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 Manufacturing Engineer II will be a key member of the manufacturing engineering team, partnering with Management, Quality Assurance, Product Development, Supply Chain/ Logistics and Production. This role is responsible for executing manufacturing engineering activities in compliance with cGMP requirements, applicable regulatory standards, and site procedures, while ensuring deliverables are completed on time and to a high standard of quality. 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. Primary Responsibilities Serve as the Manufacturing Process SME for product packaging and labeling, with ownership of production line setup, packaging configuration, labeling process, MRP setup, and manufacturing readiness to support on-time shipment of clinical products. Provide day-to-day production support to help ensure staff remain engaged, on task, and consistently adhere to GMP and established manufacturing procedures. Develop, maintain, and continuously improve manufacturing documentation, including manufacturing procedures, travelers/ device history records, BOMs, work instructions, and product specifications. Own and maintain the applicable process risk documentation and participate in risk analysis as needed. Co-own and maintain more than 50 packaging and labeling specifications and their associated manufacturing procedures, ensuring alignment with approved product configurations and labeling requirements. Partner closely with Supply Chain, Logistics, Quality, Regulatory, R&D, and Production to support production and clinical shipment schedules. Lead and support engineering changes related to packaging and labeling, including process improvement, documentation updates, product configuration changes, and implementation of corrective actions. Respond effectively to changing priorities and urgent field or clinical shipment needs while maintaining compliance with established manufacturing and quality system requirements. Understand packaging validation principles and applicable requirements to assess the impact of packaging changes, and provide appropriate engineering justification. Support commercial production scalability during site transfers and manufacturing expansion, including capacity planning, production line setup, equipment implementation, and equipment/process qualification. Design and develop manufacturing fixtures and tooling to improve process consistency, ergonomics, efficiency, and manufacturability. Apply 5S, standard work, and Lean and Six Sigma principles to improve workflow, reduce waste, and support scalable manufacturing operations. Ensure compliance with Anteris Quality System and applicable SOPs. Demonstrate strong attention to detail to identify procedural gaps, documentation inconsistencies and opportunities for process improvement. Support NCMRs, CAPAs, including root cause investigation, implementation of cor