Medical Device NPI Engineer II: Process & Transfer

Cook Group; Bloomington (IN); On-site; USD 75,000 - 105,000; Full time

Job summary

Cook Group in Bloomington, IN seeks an NPI Engineer II to bridge product development with manufacturing engineering, quality, and operations. You will configure and optimize processes for manufacturing new medical devices, evaluate DF(M)A options, and support design-for-manufacturability and value engineering initiatives.

Responsibilities include developing new processes, validating them, documenting PFMEAs and drawings, and collaborating with R&D and Operations to transfer projects to

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.
• Working knowledge of Microsoft Office Software (ie Word, Excel, Visio, Power point, MS Project)
• Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc)

Responsibilities

• Collaborate in a team of engineers focused on design, development, and implementation of new processes (within Cook Inc Facilities) required for the manufacture of new device designs.
• Execute methods needed for compliant, efficient and effective process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection and specification development).
• Utilize and apply a risk based approach during the development, implementation, and validation of all processes.
• Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with new products.
• Collaborate with R&D team, Operations, and Production engineering to ensure the effective completion of all activities associated with transfer to manufacturing of an R&D Engineering project / objective.
• Advice new product development team on making vs. buying decisions for components.
• Define, identify, and procure new equipment for manufacturing processes.
• Ability to complete projects within specific time lines and meeting performance expectations.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Maintain regular and punctual attendance
• Must have effective oral, written and presentation communication skills
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Represent Operations Principles of the Cook Operating System
• Champion line start up, support, and training
• Promote and driven integrated manufacturing, driving quality at source.

Skills

Process validation

Design for manufacturing

Lean manufacturing

Statistical analysis

Problem solving

MS Office (Word/Excel/PowerPoint)

Cross-functional collaboration

Education

Bachelor's degree in Engineering, or Engineering Technology

Tools

Creo

SolidWorks

MS Project

Visio

Job description

Cook Group in Bloomington, IN seeks an NPI Engineer II to bridge product development with manufacturing engineering, quality, and operations. You will configure and optimize processes for manufacturing new medical devices, evaluate DF(M)A options, and support design-for-manufacturability and value engineering initiatives.

Responsibilities include developing new processes, validating them, documenting PFMEAs and drawings, and collaborating with R&D and Operations to transfer projects to