Director of Medical Device Injection Molding Ops

MRINetwork Jobs; Springfield (IL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Job summary

MRINetwork Jobs is seeking an experienced Operations Manager to oversee the plastic injection molding facility producing medical device components. The role emphasizes regulatory compliance with ISO 13485 and FDA guidelines, and relentless focus on safety, quality and efficiency.

You will lead cross‑functional teams, drive continuous improvement, and develop strategic plans to meet customer demand while controlling costs and budget targets.

Qualifications

• Bachelor’s degree in Engineering, Operations Management, or related field.
• 7+ years in manufacturing leadership, with 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 injection molding operations to meet safety, quality, delivery, and cost goals.
• Ensure compliance with ISO 13485, FDA cGMP, and quality system requirements.
• Develop and implement operational policies, procedures, and best practices.
• Collaborate with management to evaluate manufacturing feasibility for quotes on new and existing products.
• Forecast operating costs and direct preparation of budget requests.
• Lead development of the strategic plan and Annual Operating Plan for the function.
• Manage staffing, training, performance reviews, and development of team members.
• Monitor KPIs and use data to identify improvements in efficiency, scrap reduction, and downtime.
• Coordinate production activities with planning and distribution.

Skills

Leadership

Problem-solving

Organizational skills

Communication

Education

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

Tools

MS Excel

MS Word

MS PowerPoint

Job description

MRINetwork Jobs is seeking an experienced Operations Manager to oversee the plastic injection molding facility producing medical device components. The role emphasizes regulatory compliance with ISO 13485 and FDA guidelines, and relentless focus on safety, quality and efficiency.

You will lead cross‑functional teams, drive continuous improvement, and develop strategic plans to meet customer demand while controlling costs and budget targets.