Value Stream Manager

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 supervisionof 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 willdirectly manageoperations technicians, operators,managers,supervisors,and process engineers.

KEY RESPONSIBILITIES 

• Ensures the safety of colleagues through effective and continuously improving environmental, health, andsafety 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 accident, near miss, and incident event notifications.  

• Lead, coach, and develop a team oftechnicians, operators,managers,supervisors,andprocess engineers.

• 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 amemberof the site leadership team participating in strategic and tactical planning & execution to ensure site objectives are met.  Ensure alignment of value streamobjectiveswith overall siteobjectives.

• Foster a culture of colleague engagement thru positive leadership, recognition, accountability, feedback, continuous improvement, and engagement activities

• Responsible for the team’s compliance and meeting thequality standards as defined by Integra’s SOPs, GMPs, Global QualityStandards, local and procedures, where applicable.  Partner with QualityAssurance 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/TMVvalidations for equipment and processes to meet the demands of new productintroductions 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 toidentifyroot causesand 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 delivering 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, approves, and 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.  Interacts 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 experienceORMaster degree with5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience

• Demonstrate excellent organizational andenglishcommunication skills (oral & written)

• Financial acumen relating tooperations 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.

• Experience in regulated environment; medical device or pharma preferred

• Self-motivated team player with ability to workindependently and collaboratively across all levels of the organization.

Tools And Equipment Used

This role requires regular use of tools and equipment relevant to the work environment. Examples include:

• 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 DisabilitiesAct (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 totwenty-fivepounds.

• Travel domestically and internationally via car, train, or airplane, as required by the role.

ADVERSE WORKING CONDITIONS

The conditions listed below represent environmentalfactorswhich the employee may be exposedto whileperforming 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 protocolsand 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 responsibilitiesand duties outlinedabove 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.Additionalduties may be assigned asappropriate tomeet business needs.

This job description does notconstitutea contract of employment and is subject to change at the discretion of the employer, based on evolving organizational requirements and role expectations.