MES Program Manager Medical Device Manufacturing
Danvers MA
Job Summary:
Key Responsibilities:
- Lead MES implementation projects ensuring alignment with medical device manufacturing standards (FDA GMP ISO).
- Integrate MES with ERP and shop floor systems optimizing realtime data exchange and production workflows.
- Collaborate with crossfunctional teams (IT Quality Operations) for seamless system adoption.
- Ensure compliance with FDA GMP and ISO regulations generating reports for production traceability.
- Identify opportunities for process improvements and cost reductions through MES enhancements.
Qualifications:
- Education: Bachelors in Engineering Computer Science or related field.
- Experience: 8 years in manufacturing with 5 years in MES management; experience in medical devicemanufacturing required.
- Familiarity with MES platforms (e.g. Siemens Rockwell) and regulatory compliance in medical devices.
- Strong project management and leadership skills in FDA/GMP environments.
Preferred:
- PMP certification or similar.