Operations Leader – Medical Device Injection Molding

Flex; United States; On-site; USD 110,000 - 180,000; Full time

Benefits offered by this job

Medical/Dental/Vision

Life Insurance

Disability Insurance

401(k) Matching

Job summary

Flex is seeking an experienced Operations Manager to oversee our plastic injection molding facility producing medical device components in the United States. You will manage production, collaborate with program management, quality, engineering, maintenance, and supply chain to ensure compliance with ISO 13485, FDA regulations, and internal standards.

The ideal candidate will lead with strong manufacturing knowledge, embrace continuous improvement, drive Lean/Six Sigma initiatives, and develop

Qualifications

• Bachelor's degree in Engineering, Operations Management, or related field required.
• Minimum 7 years in manufacturing leadership; 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.
• Excellent leadership, problem-solving and communication skills.

Responsibilities

• Oversee daily injection molding operations 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.
• Collaborate with management to evaluate manufacturing feasibility for quotes.
• Forecast operating costs and direct budget requests.
• Develop strategic plans and annual operating plan for the function.
• Manage staffing, training, performance reviews, and development of team members.
• Monitor KPIs and use data to drive improvements in efficiency, scrap reduction, and downtime.

Skills

Leadership

Problem-solving

Communication

Organizational skills

Lean Manufacturing

Six Sigma

Office skills

Education

Bachelor's degree in Engineering, Operations Management, or related field

Tools

Office software

Job description

Flex is seeking an experienced Operations Manager to oversee our plastic injection molding facility producing medical device components in the United States. You will manage production, collaborate with program management, quality, engineering, maintenance, and supply chain to ensure compliance with ISO 13485, FDA regulations, and internal standards.

The ideal candidate will lead with strong manufacturing knowledge, embrace continuous improvement, drive Lean/Six Sigma initiatives, and develop