Director of Operations
Listed on 2026-01-11
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Engineering
Operations Manager, Manufacturing Engineer
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.
As we continue to scale, Anteris is seeking a Director of Operations to lead manufacturing and operational performance for our Delivery System, Sheath, and Crimper product lines. This role owns end-to-end responsibility for operational execution and engineering oversight across both internal manufacturing and third-party suppliers, with an initial focus on stabilizing external manufacturing performance and evaluating opportunities to insource critical capabilities over time.
This is a highly visible leadership role requiring deep experience in catheter-based medical device manufacturing, strong operational discipline, and the ability to partner effectively across Operations, Engineering, Quality, and Supply Chain to deliver reliable, scalable production in a regulated environment.
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.
Key Responsibilities Operational Strategy & Execution- 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…
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