Supports product engineering for medical organ-perfusion devices, including design changes, verification, troubleshooting, root-cause analysis, testing, prototyping, and continuous improvement. Collaborates with product development, operations, quality, customer service, suppliers, and manufacturers. Creates technical documentation, design history files, device master records, assembly instructions, test strategies, and regulatory-quality reports in compliance with ISO 13485 and applicable procedures.

The Operations Manager coordinates U.S. distribution, warehousing, inventory, logistics, and supply chain activities. Responsibilities include managing logistics partners, maintaining inventory accuracy and safety stock, monitoring KPIs, improving operational performance, mapping distribution networks, mitigating supply chain risks, and supporting business continuity. The role also involves team development, cross-functional collaboration, supplier management, reporting, and continuous improvement. This is an on-site position with up to 10% domestic and international travel.

Lead data quality and reporting for complaints and servicing systems: cleanse and validate data, build reports and dashboards, perform advanced statistical analyses, automate data extraction, maintain databases, and collaborate with stakeholders to surface actionable insights and process improvements.