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 Manager is responsible for end-to-end performance of CSS medical device production value stream platform. The responsibilities include acceptance of design transfers, through lifecycle management to final device shipment. He/She 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 will be 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). Ensuring the production of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR and other applicable regulatory agencies.
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 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,trainingand 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 engagement thru 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 QualityAssurance and Regulatory Affairs to ensure full compliance with applicable standards (FDA QSR, GMP, ISO 13485,etc).
Initiate,developand 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/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,practicesand 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 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.
Experience in regulated environment; medical device or pharma preferred
Self-motivated team player with ability to 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 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 o
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