Director of Operations

Anteris is a science-driven structural heart company redefining expectations through cutting-edge solutions focused on restoring native-like physiology rather than treating symptoms of structural heart disease. We are developing a new class of TAVR designed to replicate the performance of a healthy aortic valve. With offices in Minneapolis, MN (US);
Geneva, Switzerland; and Brisbane and Perth, Australia, Anteris is a growing, global, and inclusive organization.

• Own manufacturing and operational performance for Delivery System, Sheath, and Crimper product lines across internal and external manufacturing environments.
• Accountable for Safety, Quality, Delivery, and OCOG performance.
• Develop and execute multi-year operational strategies aligned with business objectives and board-level financial decisions.
• Translate long-range plans into actionable KPIs, project roadmaps, budgets, and staffing models.
• Maintain robust project management and operating cadence to ensure execution against SQDC metrics.
• Provide leadership to cross-functional Operations, Manufacturing, and Product Development Engineering teams.
• Own area budgets, capacity planning, product forecasting, and production scheduling for both internal and outsourced products.

• Lead recovery and performance improvement initiatives with third-party medical device manufacturers producing finished catheter-based devices.
• Build strong, accountable partnerships with CMOs and critical suppliers, driving quality, delivery, and cost improvements.
• Define and execute outsourcing and in sourcing strategies, including risk mitigation and capability assessments.
• Oversee supplier qualification, governance, and performance management in a highly regulated environment.

• Provide leadership-level oversight to Product Development Engineering teams supporting Delivery System devices.
• Lead or support development and execution of Master Validation Plans, including IMV/TMV strategies and IQ/OQ/PQ activities.
• Ensure robust process development, transfer, and validation to support scalable manufacturing and regulatory compliance.
• Partner closely with Quality and Regulatory to ensure alignment between process design, validation, and compliance requirements.

• Build and scale manufacturing operations using Lean, Toyota Production System, and Six Sigma fundamentals.
• Deploy Operational Excellence tools to improve productivity, reduce cost, and stabilize processes.
• Develop long-range models for OCOG, staffing, space, and site capacity.
• Lead Kaizen and cross-functional improvement initiatives across Operations and Engineering.

• Attract, develop, and retain high-performing Operations and Engineering talent.
• Build leadership capability and succession pipelines as the organization scales.
• Foster strong cross-functional collaboration and accountability.

• Bachelor’s degree in Engineering, Operations Management, or related field required; MBA or advanced degree preferred.
• Must have 10+ years of progressive leadership experience in Operations and Engineering within the medical device industry, with strong preference for catheter-based devices.
• Demonstrated leadership experience across:
• Third-party medical device supplier development and CMO management
• Scaling manufacturing operations from early-stage or growth environments
• Process development, transfer, and validation (IMV/TMV/IQ/OQ/PQ)
• Deep expertise in Lean, Toyota Production System, and Six Sigma methodologies.
• Proven success leading transformational change in fast-growing or evolving organizations.
• Experience with multi-site and/or global manufacturing operations.
• Strong understanding of FDA regulations, ISO standards, and regulatory impact on manufacturing processes.
• Strong financial and operational acumen.
• Collaborative, servant-leader mindset with a track record of building cross-functional partnerships.
• Willingness to travel; expected travel