Value Stream Manager

The Value Stream Manager 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 supervisionof the Plant Managerthe 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 ISO 9001 ISO 13485 EU MDR the Canadian Medical Device Regulations (CMDR) and other applicable regulatory agencies.

SUPERVISION EXERCISED

Position willdirectly manageoperationstechnicians operators supervisorsand 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 compliantregardingsafety procedures policies permits practices PPE proper housekeeping and awareness.Initiates andleadaccident near miss and incident event notifications.

• Lead coach and develop a team of supervisors and managers.Responsible for managing staffingtrainingand daily maintenance operations across shifts up to 7 days a week including attendance overtime operational issues talent management performance management developmentplanningand reporting of results. Interviews job candidates completes performance reviews and justifies promotions or disciplinary actions (asappropriate).

• Serve as a member of the site leadership teamparticipatingin strategic and tactical planning & execution to ensure siteobjectivesare met.Ensure alignment of value streamobjectiveswith overall siteobjectives.

• Foster a culture of colleague engagementthrupositive leadership recognition accountability feedback continuous improvement and engagement activities

• Responsible for the teams compliance and meeting the quality standards as defined by Integras 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 13485etc).

• Initiatedevelopand 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/nonconformancesidentifyroot cause areappropriately corrected with sustainable remediations.Leverage data/tools/techniques toidentifyroot 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 systemin a timely manner.

• Coach/mentorleansix-sigma manufacturing initiatives (5S Kaizen Value Stream Mapping Kanban Standard Work. OEE) to reduce waste and improve flow across the value stream.

• Ensure teamsdeliveringmeasurable 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 (CoPQCpk 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 conceptspracticesand approaches as well as with senior levelvendoror 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 experienceORMasterdegree with 5 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

• Proficiencyin 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 withabilityto work independently 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 withthe 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 movethroughoutvarious 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 protocols and personal protective equipment (PPE) areand provided.In accordance withthe 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 notrepresentan exhaustive list of all tasks that may be.Additionalduties may be assigned asappropriate tomeet business needs.

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