Sr. Manager, Value Stream

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 Sr. Manager, Value Stream leader is responsible for end-to-end performance of a medical device production value stream. Manufacturing team leader and owner of the VS — from 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. He/She is 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). They ensure the production of medical products 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 supervisors and process engineers and indirectly technicians and operators in the production of medical devices. Primarily machining and assembly operations. Key Responsibilities Ensures the safety of colleagues through effective and continuously improving environmental, health, and safety program engagement. Ensure all team members receive training, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, PPE, proper housekeeping, and awareness. Initiates and lead accidents, near miss, and incident event notifications. Lead, coach, and develop a team of supervisors and managers. Responsible for managing 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. Interviews job candidates, completes performance reviews, and justifies promotions or disciplinary actions (as appropriate). Serve as a member of the site leadership team participating in strategic and tactical planning & execution to ensure site objectives are met. Ensure alignment of value stream objectives with overall site objectives. Foster a culture of colleague engagement through positive leadership, recognition, accountability, feedback, continuous improvement, and engagement activities Responsible for the team’s compliance and meeting the quality standards as defined by Integra’s SOPs, GMPs, Global Quality Standards, local and procedures, where applicable. Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable standards (FDA QSR, GMP, ISO 13485, etc). Initiate, develop and implement engineering studies and IQ/OQ/PQ/TMV validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations. Coordinate specific efforts as required by the project team. Includes such tasks as development of manufacturing process requirements, specifications, Failure Mode Effects Analysis (FMEA), validations, Engineering Change Requests/Orders (ECR/ECO) and Engineering Drawings. Ensures investigations/CAPAs/nonconformances identify root cause, are appropriately corrected with sustainable remediations. Leverage data/tools/techniques to identify root causes and implement sustainable corrective actions. Ensure training and process documentation requirements are consistently met. Partner with supplier quality and procurement to ensure supplier issues and changes are addressed appropriately within quality management system in a timely manner. Coach/mentor lean six-sigma manufacturing initiatives (5S, Kaizen, Value Stream Mapping, Kanban, Standard Work. OEE) to reduce waste and improve flow across the value stream. Ensure teams deliver measurable improvements in yield, throughput, and cycle time across the value streams in line with KPI targets. Partner with the cross-functional teams to meet customer fulfillment needs as well as lead process optimization, yield improvement, six sigma process excellence and lean projects. Monitor process capability and performance metrics (CoPQ, Cpk, yield, run time, downtime, scrap). Develop process/project improvement and mitigation projects to improve capability and performance. Develops, reviews,