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 medical device production value stream. The role is a manufacturing team leader and owner of the value stream—from acceptance of design transfers, through lifecycle management to final device shipment. Under direct supervision of the Plant Manager, the Value Stream Manager implements strategies and plans to meet short‑ and long‑term goals, achieving the highest standards of safety, quality, customer service, and productivity.

Responsibilities span safety and security, manufacturing, engineering, quality, regulatory, and project management, all measured by safety, quality, delivery, and cost key performance indicators (KPI’s). The manager ensures production of medical products complies with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

Position directly manages operation technicians, operators, supervisors, and process engineers.

• Ensures colleague safety through continuous improvement of the environmental, health, and safety program. Provides training and ensures compliance with safety procedures, policies, permits, practices, PPE, housekeeping, and awareness. Initiates accident, near‑miss, and incident event notifications.
• Leads, coaches, and develops a team of supervisors and managers. Manages staffing, training, and daily maintenance operations across shifts for 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 as appropriate.
• 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 team compliance with quality standards defined by SOPs, GMPs, Global Quality Standards, local procedures, and partners with Quality Assurance and Regulatory Affairs to maintain full compliance (FDA QSR, GMP, ISO 13485, etc.).
• Initiates, develops, and implements engineering studies and IQ/OQ/PQ/TMV validations for equipment and processes supporting new product introductions and current manufacturing operations. Coordinates specific efforts as required by the project team, including manufacturing process requirements, specifications, FMEA, validations, Engineering Change Requests/Orders (ECR/ECO), and Engineering Drawings.
• Investigates CAPAs and nonconformances to identify root causes, ensuring appropriate corrective actions with sustainable remediation. Leverages data, tools, and techniques to implement sustainable corrective actions.
• 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 in a timely manner.
• Coaches/mentors lean Six‑sigma manufacturing initiatives (5S, Kaizen, Value‑Stream Mapping, Kanban, Standard Work, OEE) to reduce waste and improve flow across the value stream.
• Delivers measurable improvements in yield, throughput, and cycle time across the value streams in line with KPI targets.
• Partners with cross‑functional teams to meet customer fulfillment needs, leads process optimization, yield improvement, Six‑sigma process excellence, and lean projects. Monitors process capability and performance metrics (CoPQ, Cpk,…