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 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 (KPIs). They ensure the production of medical products in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO9001, ISO13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. SUPERVISION EXERCISED Position will directly manage operations technicians, operators, supervisors, and process engineers. 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 leads accident, 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 procedures, where applicable. Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable standards (FDA QSR, GMP, ISO13485, 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 the 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 delivering measurable improvements in yield, throughput, and cycle time across the value streams in line with KPI targets. Partner with 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. Develop, review, approve, and be accountable for all financial budgets within the value stream, including headcount, expense, capital, and inventory. Ensure value stream cost of goods sold (COGS) results are in line with financial targets by ensuring bill‑of‑materials (BOMS), routers, and process instructions align to costs. Work cross‑functionally and collaboratively to solve operational issues. Interact with senior management on matters concerning several job areas, departments, and/or customers to accept new concepts, practices and approaches as well as with senior level vendor or customer representatives concerning projects & operational decisions. Complete other job-related duties as assigned. SKILLS & COMPETENCIES Engineering or Technical degree with 8+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience. OR Master’s degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience. Demonstrate excellent organizational and English communication skills (oral & written). Financial acumen relating to operations profit & loss (P&L) items. Proficiency in MS Office Suite and statistical analysis software. Experience in regulated environment; medical device or pharma preferred. Familiarity with health, safety, and environmental regulations related to manufacturing. Self‑motivated team player with ability to work independently and collaboratively across all levels of the organization. TOOLS AND EQUIPMENT USED General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems. Software and systems: ERP systems (e.g., Oracle), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms. PHYSICAL REQUIREMENTS The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties. While performing the responsibilities of this role, the employee is expected to: Sit, listen, speak, and move throughout various areas of the building. Travel across all company locations as needed. Periodically lift and/or move items up to twenty‑five pounds. Travel domestically and internationally via car, train, or airplane, as required by the role. ADVERSE WORKING CONDITIONS The conditions listed below represent environmental factors which the employee may be exposed to while performing the essential duties of this position. These reflect a general plant or service environment. Adverse exposure may include handling hazardous and biohazardous materials such as: Flammable and corrosive liquids Compressed gases Sharps Medical waste Appropriate safety protocols and personal protective equipment (PPE) are required and provided. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role. DISCLAIMER The responsibilities and duties outlined above are intended to illustrate the general nature and level of work performed by individuals assigned to this position. They do not represent an exhaustive list of all tasks that may be required. Additional duties may be assigned as appropriate to meet business needs. This job description does not constitute a contract of employment and is subject to change at the discretion of the employer, based on evolving organizational requirements and role expectations. SALARY & BENEFITS Salary Pay Range: $95,000.00 – $130,000.00 USD Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job‑related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Additional Description for Pay Transparency: Subjects to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and savings plan (401(k)). Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you’d like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans. Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at View email address on click.appcast.io. ERASE-RELATED LINKS Integra – Employer Branding from Integra LifeSciences on Vimeo. #J-18808-Ljbffr