NPI Manufacturing Engineer II (Medical Devices)

Cook Medical; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Cook Inc - Bloomington seeks a Manufacturing Engineer 2 for NPI to bridge product development with manufacturing. You will configure and optimize processes to produce new medical devices and evaluate design for manufacturability and value engineering options.

Responsibilities include collaborating with R&D, Operations and QA, documenting PFMEA and work instructions, validating processes, selecting equipment, and supporting line startup and transfer to production.

Qualifications

• Bachelor's degree in Engineering or Engineering Technology.
• Minimum of 2+ years experience 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 principles.
• Knowledge of medical device quality standards ISO13485/FDA practices, GMP and similar regulated industry standards.
• Experience using analytic skills and problem solving.
• Proficiency with Microsoft Office Suite (Word, Excel, Visio, PowerPoint, MS Project).
• Experience with 3D modeling software (Creo, SolidWorks).

Responsibilities

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

Skills

Analytical skills

Problem solving

Communication skills

Teamwork

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Creo

SolidWorks

Microsoft Office

Visio

PowerPoint

MS Project

Job description

Cook Inc - Bloomington seeks a Manufacturing Engineer 2 for NPI to bridge product development with manufacturing. You will configure and optimize processes to produce new medical devices and evaluate design for manufacturability and value engineering options.

Responsibilities include collaborating with R&D, Operations and QA, documenting PFMEA and work instructions, validating processes, selecting equipment, and supporting line startup and transfer to production.