Manufacturing Engineer II — Medical Devices

Cook Group; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Cook Group in Bloomington, IN is seeking a Manufacturing Engineer 2 to plan, direct, and optimize medical device manufacturing processes. You will work with Operations, Quality Assurance, and Regulatory Affairs to improve throughput, reduce costs, and enhance product quality.

The role requires a Bachelor's degree in Engineering and 5–7 years in quality or manufacturing engineering, with knowledge of medical device regulations and project management experience.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5–7 years in Quality Engineering, Manufacturing Engineering or Development Engineering.
• Knowledge of medical device regulations, pertinent standards and guidelines.
• Project management experience and ability to manage multiple activities (preferred).

Responsibilities

• Develop, maintain, and improve manufacturing and inspection processes/procedures.
• Perform equipment and process validations and testing to internal procedures and external standards.
• Define equipment maintenance requirements and improve tooling/equipment.
• Collaborate with Operations, QA, Regulatory Affairs, and suppliers to resolve issues.
• Support NCRs, CAPAs, and change evaluations related to manufacturing processes or products.
• Drive continuous improvement to reduce downtime and improve lead times.

Skills

Quality tools

Project management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Engineering or related field

Job description

Cook Group in Bloomington, IN is seeking a Manufacturing Engineer 2 to plan, direct, and optimize medical device manufacturing processes. You will work with Operations, Quality Assurance, and Regulatory Affairs to improve throughput, reduce costs, and enhance product quality.

The role requires a Bachelor's degree in Engineering and 5–7 years in quality or manufacturing engineering, with knowledge of medical device regulations and project management experience.