Manufacturing Operations Manager | Medical Device

Our client is seeking an experienced Operations Manager / Production Manager to lead manufacturing operations within a highly regulated production environment. This is a key site leadership position responsible for production performance, workforce leadership, production planning, regulatory compliance, and the execution of the annual manufacturing plan.

The ideal candidate is a hands-on manufacturing leader who combines strong technical and operational knowledge with the ability to develop supervisors, build accountability, and drive performance across a production organization of approximately 50+ employees
.

Medical device manufacturing experience is strongly preferred
, particularly experience operating under FDA, MDR, ISO, cGMP, and/or TÜV requirements
. Candidates from similarly regulated manufacturing environments may also be considered based on the strength of their production leadership and demonstrated ability to successfully learn and operate within new regulatory frameworks.

• Lead day-to-day manufacturing and production operations
  , ensuring achievement of safety, quality, delivery, productivity, and cost objectives.
• Develop and execute production plans by aligning labor, equipment, materials, capacity, and production schedules with site requirements and customer demand.
• Lead an operations organization of approximately 50-55 employees
  , including approximately five direct reports and frontline production leadership.
• Coach, mentor, and develop production supervisors, technical specialists, and emerging leaders
  , strengthening accountability and overall team performance.
• Establish clear performance expectations and provide consistent performance management, feedback, and employee development.
• Partner closely with Quality, Supply Chain, Engineering, Technical Services, Maintenance, Procurement, Finance, EH&S, and Training to ensure successful execution of production plans.
• Maintain production operations in accordance with applicable FDA, MDR, cGMP, OSHA, EH&S, and quality-system requirements
  .
• Support regulatory and quality compliance by identifying operational risks and ensuring manufacturing activities are executed within established procedures and controls.
• Monitor production performance through KPIs and operational metrics
  , identifying opportunities to improve throughput, efficiency, quality, labor utilization, and cost.
• Lead structured problem-solving and root cause analysis
  , supporting corrective and preventive actions when production or quality performance does not meet expectations.
• Drive continuous improvement and operational excellence initiatives across manufacturing operations.
• Coordinate resources and cross-functional support for strategic production improvements, equipment upgrades, process enhancements, and operational projects.
• Provide production and resource-planning input into budgeting, forecasting, and expense-management activities
  .
• Develop and manage operational plans involving resource, time, labor, equipment, and material allocation.
• Work effectively across organizational boundaries and build alignment among internal teams, vendors, contractors, engineering resources, and other stakeholders.
• Manage multiple operational priorities and projects simultaneously while maintaining production commitments and regulatory compliance.
• Foster a manufacturing culture centered on safety, quality, accountability, teamwork, employee engagement, and continuous improvement
  .

• Bachelor's degree in Engineering, Manufacturing, Operations Management, or a related technical discipline preferred. Equivalent extensive manufacturing experience may be considered.
• 10+ years of progressive manufacturing and operations leadership experience within a regulated production environment.
• Medical device manufacturing experience strongly preferred.
• Demonstrated experience leading sizable manufacturing organizations, ideally 50+ production employees through frontline supervisors or other production leaders
  .
• Strong working knowledge of regulated manufacturing requirements, preferably including FDA and MDR regulations applicable to medical device manufacturing.
• Experience working within TÜV and/or ISO-regulated quality systems is highly desirable.
• Pharmaceutical or other highly regulated manufacturing experience may be considered, particularly when combined with demonstrated success learning and implementing new regulatory requirements.
• Strong knowledge of production planning, capacity planning, labor scheduling,…