Senior Production Manager - Medical Device Lean Leader On-Site

CoWorx Staffing Services; Mansfield (MA); On-site; USD 115,000 - 125,000; Full time

Job summary

CoWorx Staffing Services in Mansfield, MA seeks an experienced Production Manager to lead manufacturing for an FDA-regulated medical device program. On-site, Mon-Fri, 8:00 AM-5:00 PM, you will drive safety, quality, delivery, and cost objectives while scaling operations.

The ideal candidate has 10+ years in electromechanical manufacturing and 5+ years in medical devices, with strong FDA/ISO13485 experience and a proven leadership track record.

Qualifications

• 10+ years in complex electromechanical manufacturing
• 5+ years in medical device manufacturing (preferably 10+ years)
• Experience with FDA-regulated quality systems and ISO 13485 environments
• Proven success leading production teams and driving improvements
• Electromechanical assembly experience
• Excellent verbal and written communication abilities
• Experience with Class II/III medical devices
• Implantable medical device manufacturing experience
• Cleanroom manufacturing experience
• Advanced Lean Manufacturing expertise

Responsibilities

• Provide overall production leadership focused on safety, quality, delivery, and cost objectives.
• Lead manufacturing operations to meet production schedules and customer demand.
• Drive continuous improvement and Lean Manufacturing initiatives across the facility.
• Partner with Planning, Supply Chain, Engineering, Quality, and Operations teams to ensure successful execution.
• Develop, mentor, and lead production personnel while building a high-performance culture.
• Monitor and improve key performance metrics related to productivity, quality, and delivery.
• Ensure compliance with FDA regulations, ISO 13485 standards, and company procedures.
• Communicate effectively with internal stakeholders and strategic OEM customers.
• Support manufacturing scalability for growing product demand and future business opportunities.

Skills

Electromechanical assembly

Lean manufacturing

Leadership

FDA compliance

Medical device manufacturing

Communication

ISO 13485

Class II/III devices experience

Implantable device manufacturing

Cleanroom experience

Advanced Lean

Education

Bachelor's degree in Operations/Engineering/Manufacturing

Job description

CoWorx Staffing Services in Mansfield, MA seeks an experienced Production Manager to lead manufacturing for an FDA-regulated medical device program. On-site, Mon-Fri, 8:00 AM-5:00 PM, you will drive safety, quality, delivery, and cost objectives while scaling operations.

The ideal candidate has 10+ years in electromechanical manufacturing and 5+ years in medical devices, with strong FDA/ISO13485 experience and a proven leadership track record.