Value Stream Manager

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Value Stream Manager is responsible for end-to-end performance of a Tissue Technology medical device production value stream platform. Work includes acceptance of design transfers, through lifecycle management to final device shipment. Under direct supervision of the Plant Manager, the Value Stream Manager will be responsible for implementing strategies and plans to meet short and long-term goals to achieve the highest standards of safety, quality, customer service, and productivity.

They are responsible for all aspects of safety and security, manufacturing, engineering, quality, regulatory, and project management within the value stream as measured by safety, quality, delivery, and cost key performance indicators (KPI's). He/She will ensure the production of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

SUPERVISION EXERCISED

Position will directly manage operations technicians, operators, managers, supervisors, and process engineers.

• Ensures the safety of colleagues through continuous improvement of the environmental, health, and safety program. Provides training and ensures compliance regarding safety procedures, policies, permits, practices, PPE, housekeeping, and awareness. Initiates and leads accident, near‑miss, and incident event notifications.
• Leads, coaches, and develops a team of technicians, operators, managers, supervisors, and process engineers.
• Manages staffing, training, and daily maintenance operations across shifts up to 7 days a week, including attendance, overtime, operational issues, talent management, performance management, development planning, and reporting of results. Conducts interviews, performance reviews, and justifies promotions or disciplinary actions.
• Serves as a member of the site leadership team, participating in strategic and tactical planning & execution to ensure site objectives are met. Aligns value‑stream objectives with overall site objectives.
• Fosters a culture of colleague engagement through positive leadership, recognition, accountability, feedback, continuous improvement, and engagement activities.
• Ensures the team’s compliance with quality standards defined by SOPs, GMPs, global quality standards, local procedures, and partners with Quality Assurance and Regulatory Affairs to maintain compliance with FDA QSR, GMP, ISO 13485, etc.
• Initiates, develops, and implements engineering studies and validations (IQ/OQ/PQ/TMV) for equipment and processes, including development of manufacturing process requirements, specifications, FMEA, validations, ECR/ECO, and engineering drawings.
• Ensures investigations, CAPAs, and nonconformances identify root causes and are corrected with sustainable remediations, using data, tools, and techniques.
• Ensures training and process documentation requirements are consistently met.
• Partners with supplier quality and procurement to address supplier issues and changes within the quality management system timely.
• Coaches and mentors lean six‑sigma manufacturing initiatives (5S, Kaizen, Value Stream Mapping, Kanban, Standard Work, OEE) to reduce waste and improve flow.
• Delivers measurable improvements in yield, throughput, and cycle time in line with KPI targets.
• Partners with cross‑functional teams to meet customer fulfillment needs, lead process optimization, yield improvement, and six‑sigma projects; monitors capability and performance metrics.
• Develops, reviews, and approves budgets within the value stream, including headcount, expenses, capital, and inventory.
• Maintains cost of goods sold in line with financial targets by ensuring BOMS, routers, and process…