Value-Driven Senior Manufacturing Engineer

americas-cookmedical; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Cook Medical in Bloomington, IN seeks a Manufacturing Engineer to plan, direct, and optimize manufacturing processes for medical devices. You will collaborate with Operations, QA, and Regulatory to improve designs, reduce costs, and increase throughput.

Responsibilities include working with vendors and product development to scale processes, validating protocols, and ensuring compliance with design controls and Cook's QMS.

Qualifications

• Bachelor's degree in engineering required.
• Master's degree preferred.
• Disciplines: Biomedical, Mechanical or Chemical Engineering.
• Minimum 5 years of experience in industry.
• Medical device experience.

Responsibilities

• Work with Operations Managers and outside Vendors to create methods/machines to help with manufacturing capacity of products.
• Collaborate with Product Development Engineers to develop processes for new products.
• Increase profit margins of current products which do not meet company requirements.
• Train all relevant personnel on new processes.
• Document cost savings.
• Write and execute validation protocols.
• Assure projects follow design controls established by QSPs (Quality System Procedures).
• Verify/validate critical processes or products with QA and Product Development.
• Establish project timelines and a project business case.
• Act as resource for operational departments for materials, equipment and process upgrades.
• Maintain training requirements and seek opportunities for continuous development and growth.
• Prepare and maintain accurate documentation consistent with regulations and Cook’s QMS.
• Interact effectively across the global organization with minimal supervision.
• Adhere to safety requirements.
• Maintain regular attendance and quality standards.

Skills

Communication

Team collaboration

Education

Bachelor's degree in engineering

Master's degree preferred

Biomedical/Mechanical/Chemical engineering

Tools

Lean Six Sigma

Kaizen / Continuous Improvement

Validation protocols

Job description

Cook Medical in Bloomington, IN seeks a Manufacturing Engineer to plan, direct, and optimize manufacturing processes for medical devices. You will collaborate with Operations, QA, and Regulatory to improve designs, reduce costs, and increase throughput.

Responsibilities include working with vendors and product development to scale processes, validating protocols, and ensuring compliance with design controls and Cook's QMS.