Anteris Technologies Ltd.
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.
Third‑Party Manufacturing & Supplier Development
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 insourcing strategies, including risk mitigation and capability assessments.
Oversee supplier qualification, governance, and performance management in a highly regulated environment.
Process Development, Validation & Engineering Oversight
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.
Continuous Improvement & Scaling
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.
Culture & Talent Development
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.
Skills, Knowledge, Experience & Qualifications
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 What We Offer:
Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
Collaborative and dynamic work environment with a culture of innovation and excellence.
Competitive compensation package, including salary, performance-based bonuses, and stock options.
Career development opportunities and a chance to be part of a growing company that values its employees.
Health and Wellness Offerings
Medical, Dental, and Vision Plans
Flexible Spending Account (FSA)
401k + Company Match
Life, AD&D, Short Term and Long-Term Disability Insurance
Bonus Plan Eligibility
Employee Equity Program
Paid Holidays & PTO
Employee Assistance Program
Inclusive Team Environment
Job Types: Full-time, Contract
Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.
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.
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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.
Third‑Party Manufacturing & Supplier Development
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 insourcing strategies, including risk mitigation and capability assessments.
Oversee supplier qualification, governance, and performance management in a highly regulated environment.
Process Development, Validation & Engineering Oversight
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.
Continuous Improvement & Scaling
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.
Culture & Talent Development
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.
Skills, Knowledge, Experience & Qualifications
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 What We Offer:
Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
Collaborative and dynamic work environment with a culture of innovation and excellence.
Competitive compensation package, including salary, performance-based bonuses, and stock options.
Career development opportunities and a chance to be part of a growing company that values its employees.
Health and Wellness Offerings
Medical, Dental, and Vision Plans
Flexible Spending Account (FSA)
401k + Company Match
Life, AD&D, Short Term and Long-Term Disability Insurance
Bonus Plan Eligibility
Employee Equity Program
Paid Holidays & PTO
Employee Assistance Program
Inclusive Team Environment
Job Types: Full-time, Contract
Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.
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.
#J-18808-Ljbffr