NPI Manufacturing Engineer II — Medical Device Processes

americas-cookmedical; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Job summary

Cook Medical is seeking an NPI Engineer 2 to bridge Product Development into Manufacturing Engineering, Quality and Operations. You will configure and optimize processes for manufacturing new medical devices and support DFx and value engineering initiatives.

You will collaborate with R&D, Operations and Production to transfer projects to manufacturing, qualify new processes, and help ensure on-time, compliant execution across the Cook Operating System framework.

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.
• Knowledge of process validation, design for manufacturing, statistics, and lean manufacturing.
• Experience with medical device quality standards ISO13485/FDA GMP and similar regulated standards.
• Analytical skills and problem solving.
• Proficiency with Microsoft Office (Word, Excel, Visio, PowerPoint, MS Project).
• Experience with 3D modeling software (Creo, SolidWorks).

Responsibilities

• Collaborate on design, development, and implementation of new manufacturing processes.
• Execute methods for compliant, efficient process development (DFM, validation, capability, lean, equipment specs).
• Apply a risk-based approach during development, implementation, and validation.
• Maintain process documentation (PFMEA, Production Instructions, Drawings).
• Coordinate transfer to manufacturing of R&D projects with cross-functional teams.
• Define and procure equipment for manufacturing processes.
• Support line start-up, training, and continuous improvement.
• Travel up to 10% may be required.

Skills

Analytical skills

Problem solving

Communication skills

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Microsoft Office

Visio

PowerPoint

MS Project

Creo

SolidWorks

Job description

Cook Medical is seeking an NPI Engineer 2 to bridge Product Development into Manufacturing Engineering, Quality and Operations. You will configure and optimize processes for manufacturing new medical devices and support DFx and value engineering initiatives.

You will collaborate with R&D, Operations and Production to transfer projects to manufacturing, qualify new processes, and help ensure on-time, compliant execution across the Cook Operating System framework.