Production Scheduler - Coordinator

Requirements

• Experience i n Class II or Class III medical device manufacturing
• Familiarity with FDA regulations (21 CFR Part 820) and ISO 13485
• APICS/ASCM certification (CPIM or similar)
• Experience supporting complex, high- mix or low-volume manufacturing environments
• Key Competencies
• Strong organizational and prioritization skills in a fast-paced environment
• High attention to detail with a focus on accuracy and compliance
• Effective communication across cross-functional teams
• Problem-solving mindset with the ability to adapt to changing priorities
• Ability to work independently while collaborating closely with teams
• Work Environment
• Combination of office and manufacturing floor environment
• Requires adherence to cleanroom or controlled environment procedures as applicable
• Environment can be fast-paced and high-pressure , driven by production deadlines, customer demand, and critical product timelines (including life-sustaining devices)
• Must be comfortable working around manufacturing equipment , following gowning and cleanliness requirements in controlled areas, if applicable
• Requires strong attention to detail, multitasking, and the ability to quickly adapt to shifting priorities and production constraints

Benefits

Additional Information

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 Production Scheduler - Coordinator is responsible for planning, scheduling, and coordinating production activities to ensure timely and compliant manufacturing of Class III medical devices. This role balances demand, capacity, and material availability while maintaining strict adherence to quality system regulations, including FDA and ISO standards. The position plays a critical role in ensuring on-time delivery, efficient operations, and regulatory compliance. Primary Duties & Responsibilities Production Planning & Scheduling Develop and maintain detailed production schedules based on demand forecasts, work orders, and capacity constraints Coordinate production priorities to meet customer demand, inventory targets, and project timelines Adjust schedules in response to changes in demand, material shortages, or production issues Cross-Functional Coordination Partner with Manufacturing, Quality, Engineering, and Purchasing to align production plans with operational capabilities Monitor work order progress and communicate schedule risks, delays, and recovery plans Serve as a central point of contact for production status updates Material & Inventory Alignment Ensure material availability aligns with production schedules; escalate shortages or delays Coordinate with purchasing and inventory teams to support uninterrupted production flow Support inventory accuracy and cycle count activities as needed Compliance & Documentation Ensure all scheduling and production activities align with FDA regulations, GMP, and internal quality systems (e.g., ISO 13485) Maintain accurate production records within ERP/MRP systems Support audit readiness by ensuring proper documentation and traceability of production activities Continuous Improvement Identify inefficiencies in scheduling, workflows, or production processes and recommend improvements Support initiatives to improve throughput, on-time delivery, and resource utilization Assist in developing standard work and scheduling best practices Skills, Knowledge, Experience & Qualifications Bachelor's degree required (Business Administration, Finance, or similar) 2+ years of experienc e in production scheduling, coordination, or manufacturing operations Experience working in a regulated environment (medical device, pharma, biotech, or similar) Strong understanding of ERP/MRP systems (e.g., Infor, SAP, Oracle, JD Edwards) Proficiency in Microsoft Excel and data tracking/reporting

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