Operations Manager, Medical Device Manufacturing

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

Job summary

Flex is seeking an experienced Operations Manager to oversee medical device component production in Buffalo Grove, IL. You will lead the injection molding operations, ensure regulatory compliance, and drive continuous improvement in collaboration with quality, engineering, and supply chain teams.

The role requires strong leadership, deep manufacturing knowledge, and the ability to manage KPIs, budgets, and staff development while delivering on quality and cost targets.

Qualifications

• Bachelor’s degree in Engineering, Operations Management, or related field.
• 9+ years 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.
• Excellent communication and interpersonal abilities.

Responsibilities

• Oversee daily operations of injection molding production to meet or exceed safety, quality, delivery, and cost goals.
• Ensure compliance with all regulatory and quality system requirements (e.g., ISO 13485, FDA cGMP).
• Develop and implement operational policies, procedures, and best practices.
• Collaborates with management, production, and the commercial team to evaluate manufacturing feasibility leading to quote compilation for new and existing products.
• Forecasts operating costs of department and directs preparation of budget requests.
• Partners with team and management in the development of the strategic plan and Annual Operating Plan (AOP) for the function.
• Reviews and establishes material, equipment, and manpower resource requirements.
• Prioritizes production schedules based on product introduction, equipment efficiency, and materials supply to meet customer requirements.
• Coordinates production activities with other functional groups such as planning and distribution.
• Selects and develops personnel to ensure the efficient operation of the production function.
• Accountable for controlling manufacturing operation and ensuring that production quality and cost targets are met.
• Develop customer relationships to be the partner of choice.
• Plan, organize and lead production ramps to meet customer demand increases.
• Drive continuous improvement initiatives using Lean, 5S, KAIZEN and other methodologies.
• Explores technology trends and market demand to plan projects.
• Collaborate with Engineering on design for manufacturability (DFM), mold validation, and new product introduction (NPI).
• Manage staffing, training, performance reviews, and development of team members
• Monitor KPIs and use data to identify areas for improvement in efficiency, scrap reduction, and downtime.
• Oversee plant scheduling, capacity planning, and resource allocation.
• Ensure proper preventive maintenance and readiness of molding equipment and tooling.
• Coordinate with supply chain and procurement teams to ensure material availability and inventory optimization.

Skills

Leadership

Strategic planning

Regulatory compliance

Lean Manufacturing

Six Sigma

Problem-solving

Communication

Data analysis

Team development

Education

Bachelor’s degree (Engineering/Operations Management)

Tools

Microsoft Office

ERP systems

Job description

Flex is seeking an experienced Operations Manager to oversee medical device component production in Buffalo Grove, IL. You will lead the injection molding operations, ensure regulatory compliance, and drive continuous improvement in collaboration with quality, engineering, and supply chain teams.

The role requires strong leadership, deep manufacturing knowledge, and the ability to manage KPIs, budgets, and staff development while delivering on quality and cost targets.