NPI Manufacturing Engineer II – Medical Devices

Cook Inc - Bloomington in; Bloomington (IN); On-site; USD 75,000 - 110,000; Full time

Job summary

Cook Inc - Bloomington seeks a Manufacturing Engineer 2 for New Product Introduction (NPI) to bridge product development with manufacturing, quality and operations for medical devices.

You will optimize processes, conduct design for manufacturability assessments, perform validations, and develop PFMEA and production instructions for new designs. Collaboration with R&D, operations and purchasing is expected.

Qualifications

• Bachelor's degree in Engineering or Engineering Technology.
• 2+ years in Class II/III medical device manufacturing with process and equipment validation.
• Knowledge of process validation, DFM, statistics, and lean manufacturing.
• Familiarity with ISO13485, FDA practices, GMP and related standards.
• Strong analytical and problem-solving abilities.
• Proficient with Microsoft Office (Word, Excel, Visio, PowerPoint, MS Project).
• Experience with 3D modeling tools: Creo, SolidWorks.

Responsibilities

• Collaborate in a team of engineers on new processes for device manufacture.
• Execute methods for compliant, efficient process development (DFM, validation, process capability, lean, equipment selection).
• Apply a risk-based approach during development, implementation, and validation of all processes.
• Maintain PFMEA, Production Instructions, Drawings, etc. for new products.
• Coordinate with R&D, Operations and Production for transfer to manufacturing.
• Advise on make-vs-buy decisions for components.
• Define and procure new equipment for manufacturing processes.
• Complete projects within timelines and meet performance expectations.
• Interact professionally across levels of the organization.
• Champion line start-up, support, and training.
• Promote integrated manufacturing and quality at source.

Skills

Process validation

Design for manufacturing

Statistics

Lean manufacturing

Regulatory standards ISO13485/FDA/GMP

Problem solving

MS Office Suite

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Creo

SolidWorks

Job description

Cook Inc - Bloomington seeks a Manufacturing Engineer 2 for New Product Introduction (NPI) to bridge product development with manufacturing, quality and operations for medical devices.

You will optimize processes, conduct design for manufacturability assessments, perform validations, and develop PFMEA and production instructions for new designs. Collaboration with R&D, operations and purchasing is expected.