Director, Plant Manager

About this role

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 Director, Plant Manager is responsible for developing and implementing strategies and plans to meet short and long-term goals to achieve the highest standards of safety, quality, customer service, and financials for the Integra Lifesciences Irvine, CA and Salt Lake City, UT medical device manufacturing site.  They are responsible for all aspects of safety and security, manufacturing, engineering, supply chain, facilities, and oversight for site quality, regulatory, materials, procurement, finance, human resources, product development, distribution, and service 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 manufacturing, engineering, safety, facilities and indirectly lead supply chain, procurement, human resources, and finance leaders.

KEY RESPONSIBILITIES • Responsible for ensuring the safety of all colleagues and fostering a culture of safety and compliance.  Ensure environmental, health, and safety programs are compliant, effective, and continuously improving.  Ensure accident, near miss, and incident events are managed appropriately and timely, teams are trained appropriately, and proper housekeeping is maintained.

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

• Work cross-functionally and collaboratively to solve operational issues.  Interacts with functional leadership, executives and/or major customers frequently involving special skills, such as negotiating with customers or management or influencing senior leaders.

• Lead the site in the continual pursuit of a stronger quality culture and a robust quality management system and ensure site's quality standards compliance as defined by Integra’s SOPs, GMP, Global Quality Standards, local and procedures, etc.  Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable standards (FDA QSR, GMP, ISO 13485, etc).

• Ensures robust defect processing including root cause and sustainable remediations.  Ensure operations remain in controlled and validated state (IQOQPQTMV) and is full compliance with all local regulatory QMS procedures.

• Foster a continuous improvement culture to advance operational excellence and ensure sustained improvements in manufacturing reliability, throughput, and cost effectiveness.

• Develop strategies and plans to meet/beat site productivity and service targets leveraging lean six sigma tools and techniques (5S, Kaizen, Value Stream Mapping, Kanban, Standard Work. OEE) to reduce waste and improve operational efficiency.

• Fully accountable to site’s financial performance and budget management, including oversight of headcount, operational expenses, and capital investments.  Ensure efficient allocation of resources and alignment of spending with strategic priorities.

• Develop strategies and plans to meet both short term attainment and fulfillment plans as well as long term capacity plans aligning to enterprise objectives while maintaining flexibility. 

• Complete other job-related duties as assigned.

Skills & Competencies

• Engineering or Technical degree with 10+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience OR Master degree with 8+ 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

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., SAP), 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.

Salary Pay Range:

$166,750.00 - $228,850.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related

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