Senior Production Manager – Medical Devices (Lean & GMP)

Cirtec Medical; Lowell (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Cirtec Medical Corporation in Lowell, MA seeks an experienced manufacturing leader to direct day-to-day operations in a high‑tech medical device contract manufacturing facility. You will oversee a diverse team performing manual assembly, precision machine operation, and rigorous quality inspection under ISO 13485 and FDA regulations.

You will drive Lean, 5‑S and GMP compliance, manage KPIs and visual factory tools, coordinate with development and transfer teams, and ensure safe, on‑time

Qualifications

• Bachelor's degree required.
• 5-10 years in ISO 13485 medical device environment or similar.
• Demonstrated initiative and track record of improving manufacturing processes.
• Proficient in Microsoft Office and manufacturing systems.
• Fluent in English; strong communication skills.
• Ability to read, write, and speak clearly.

Responsibilities

• Ensure conformance to ISO 13485 and company/customer requirements.
• Schedule work and manage overtime to meet commitments.
• Determine staffing needs based on production plans and capacity.
• Maintain safe practices and 5‑S standards on the shop floor.
• Use ERP/MES to ensure accurate shop floor transactions.
• Lead cross‑functional meetings and production plans.
• Coordinate with development and transfer teams on manufacturability.

Skills

Team management

Lean manufacturing

GMPs

ISO 13485

Communication

Education

Bachelor's degree

Tools

ERP

MES

Training Software

Job description

Cirtec Medical Corporation in Lowell, MA seeks an experienced manufacturing leader to direct day-to-day operations in a high‑tech medical device contract manufacturing facility. You will oversee a diverse team performing manual assembly, precision machine operation, and rigorous quality inspection under ISO 13485 and FDA regulations.

You will drive Lean, 5‑S and GMP compliance, manage KPIs and visual factory tools, coordinate with development and transfer teams, and ensure safe, on‑time