NPI Manufacturing Engineer - Medical Devices

Cook Medical; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Cook Medical is seeking a New Product Introduction Engineer to design and optimize processes for manufacturing new medical devices. You will bridge Product Development to Manufacturing Engineering, Quality and Operations, evaluating Design for Manufacturability and Value Engineering options.

Lead design for manufacturing, process validation, capability studies, equipment selection, and transfer to production, with thorough PFMEA documentation and cross-functional collaboration across R&D,

Qualifications

• Bachelor's degree in Engineering or Engineering Technology.
• Experience in Class II/III medical device manufacturing and process validation preferred.
• Knowledge of design for manufacturing, statistics and lean principles.
• Familiarity with ISO13485/FDA GMP environment.
• Strong analytical and problem-solving abilities.

Responsibilities

• Collaborate on design, development, and implementation of new manufacturing processes for device designs.
• Execute methods for compliant process development, validation, and process capability.
• Apply risk-based approaches during development, validation, and transfer to production.
• Maintain process documentation (PFMEA, work instructions, drawings).
• Coordinate cross-functionally with R&D, Operations and Production for transfers to manufacture.

Skills

Problem solving

Communication

Team collaboration

Lean manufacturing

Analytical skills

Education

Bachelor's degree in Engineering

Tools

Creo

SolidWorks

MS Office

Visio

Job description

Cook Medical is seeking a New Product Introduction Engineer to design and optimize processes for manufacturing new medical devices. You will bridge Product Development to Manufacturing Engineering, Quality and Operations, evaluating Design for Manufacturability and Value Engineering options.

Lead design for manufacturing, process validation, capability studies, equipment selection, and transfer to production, with thorough PFMEA documentation and cross-functional collaboration across R&D,