- Develops capable processes and ensures efficient and effective transfer of product into production.
- Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
- Prepares and presents technical data and recommendations at technical reviews.
- Writes validation protocols and reports applicable to new processes.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM's, Routers, FMEA's, etc.)
- Oversees development builds associated with the project using special work requests.
- Develops qualified production lines.
- Provides Design for Manufacturability (DFM) input to the engineering print package.
- Contributes ideas to or generates Intellectual Property submissions.
- Trains and/or provides work direction to technicians and may train manufacturing personnel when required as part of a validation.
- May serve as core team member or extended team member on new product projects.
- 5 - 7 years of Process Validation experience within an engineering role (R&D, Mechanical, Process, Product)
- At least 3 years of experience in the Medical Device industry as an engineer
- At least 3 years of experience with hands-on engineering exposure specific to product development
- Bachelor's Degree in engineering or relevant technical field
- Experience in clean room manufacturing highly preferred
- Experience with Nitinol manufacturing.
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Process Development Engineer - Maple Grove, United States - Insight Global
Description
Title: Process Development Engineer
Duration: 12 Month Contract
Location: on-site in Maple Grove, MN
Pay Rate: $$ /hour
Insight Global is seeking an experienced Process Owner to join a leading Medical Device company. This person will assess process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes. The person will be working with the Galway, Ireland team to transfer knowledge as related to the product.
Other responsibilities include:
Must-Haves
Pluses
