NPI Manufacturing Engineer II - Medical Devices

Cook Inc - Bloomington

Bloomington (IN)

On-site

USD 75,000 - 120,000

Full time

9 days ago

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Job summary

Cook Inc - Bloomington in Bloomington, IN seeks a Manufacturing Engineer 2 - NPI to bridge product development into manufacturing. You will configure and optimize processes to manufacture new medical devices, and evaluate DFMs and value engineering opportunities.

Responsibilities include cross-functional design and process development, risk-based validation, PFMEA documentation, and transfer-to-manufacturing activities with R&D, Operations, and Production teams. Strong communication is essential.

Qualifications

Bachelor's degree in Engineering or Engineering Technology.
Minimum 2+ years in Class II/III medical device manufacturing with qualification of new processes.
Knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles.
Knowledge of ISO13485/FDA practices, GMP and similar regulated industry standards.
Experience using analytic skills and problem solving.
Working knowledge of Microsoft Office Software (Word, Excel, Visio, PowerPoint, MS Project).
Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc).

Responsibilities

Collaborate on design, development, and implementation of new manufacturing processes for 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 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.