Senior Operations Manager - Medical Device Molding & Lean

Flex; Buffalo Grove (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

Flex is seeking an experienced Operations Manager to lead a plastic injection molding facility focused on medical device components. You will manage production, collaborate with program management, quality, engineering, maintenance, and supply chain to ensure ISO 13485 and FDA compliance while driving lean improvements.

The role requires strong leadership, strategic planning, and a track record in high‑volume manufacturing, with emphasis on cost, quality, and on‑time delivery.

Qualifications

• Bachelor’s degree in Engineering, Operations Management, or related field.
• Minimum 7 years’ experience in a manufacturing leadership role, with at least 5 years in plastic injection molding.
• Strong knowledge of medical device manufacturing standards and regulations (ISO 13485, FDA 21 CFR Part 820).
• Demonstrated experience with Lean Manufacturing and/or Six Sigma methodologies.
• Strong leadership, problem-solving, and organizational skills.

Responsibilities

• Oversee daily operations of injection molding production to meet safety, quality, delivery, and cost goals.
• Ensure compliance with regulatory and quality system requirements (ISO 13485, FDA cGMP).
• Develop and implement operational policies, procedures, and best practices.
• Collaborates with management and teams to evaluate manufacturing feasibility for quotes.
• Forecasts operating costs and directs budget requests.

Skills

Leadership

Problem solving

Communication

Data-driven decisions

Project management

Education

Bachelor’s degree in Engineering/Operations Management

Tools

Office suite

Job description

Flex is seeking an experienced Operations Manager to lead a plastic injection molding facility focused on medical device components. You will manage production, collaborate with program management, quality, engineering, maintenance, and supply chain to ensure ISO 13485 and FDA compliance while driving lean improvements.

The role requires strong leadership, strategic planning, and a track record in high‑volume manufacturing, with emphasis on cost, quality, and on‑time delivery.