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Anteris Technologies · 2 days ago

Director of Operations

Maple Grove, MN

Full-time

Onsite

Director/Executive

10+ years exp

Anteris Technologies is a science-driven structural heart company redefining expectations through cutting-edge solutions. They are seeking a Director of Operations to lead manufacturing and operational performance for their Delivery System, Sheath, and Crimper product lines, focusing on operational execution and engineering oversight.

BiotechnologyHealth CareMedical

Responsibilities

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 insourcing 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

Qualification

Catheter-based medical devicesLean methodologiesSix SigmaThird-party supplier managementProcess developmentValidationFDA regulationsISO standardsOperational acumenLeadership developmentCollaborative mindset

Required

Bachelor's degree in Engineering, Operations Management, or related field required

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

Demonstrated leadership experience across scaling manufacturing operations from early-stage or growth environments

Demonstrated leadership experience across 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 <10% annually