NPI Manufacturing Engineer II — Medical Devices

Cook Medical; Bloomington (IN); On-site; USD 85,000 - 120,000; Full time

Job summary

Cook Medical in Bloomington, IN seeks an NPI Engineer 2 to bridge product development with manufacturing engineering, quality, and operations. You will configure and optimize processes to manufacture new medical devices and evaluate DFMs and value engineering opportunities.

Responsibilities include design for manufacturing, process validation, risk-based development, and documentation such as PFMEA and production instructions, collaborating across R&D, operations, and production engineering.

Qualifications

• Bachelor's degree in Engineering or Engineering Technology.
• Minimum 2+ years in class II/III medical device manufacturing with qualification of new processes and equipment validation.
• Experience with process validation, design for manufacturing, statistics, and lean manufacturing principles.
• Knowledge of ISO13485/FDA GMP and related medical device standards.

Responsibilities

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

Skills

Analytical skills

Communication skills

Team collaboration

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Creo

SolidWorks

Microsoft Office

Job description

Cook Medical in Bloomington, IN seeks an NPI Engineer 2 to bridge product development with manufacturing engineering, quality, and operations. You will configure and optimize processes to manufacture new medical devices and evaluate DFMs and value engineering opportunities.

Responsibilities include design for manufacturing, process validation, risk-based development, and documentation such as PFMEA and production instructions, collaborating across R&D, operations, and production engineering.