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Process Development Engineer - 63184536 - TT

Job Code: 63184536
Job Location: Brooklyn Park, MN
Category: Manufacturing Engineer
Last Updated: 12/21/2018
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Job Description:
Defines, develops, designs, and validates manufacturing processes, also performs modification of existing processes for medical device assemblies and components. Works within the engineering department suggesting areas for improvements positively impacting product quality, cost and delivery.
• Creates and improves processes pertaining to:
o Feasibility Builds, Manufacturing, and Inspection
o Planning and executing process characterization activities, through tools i.e. design experiments
o Equipment selection
o Process development and documentation
o Component validation and verification samples and testing
o Develops and executes IQ, OQ and PQ protocols and reports
o Operator training
o Process Failure Mode Effects Analysis
o Clinical Builds
o Process Validation
o Assembly and Component Process flow layouts
• Involved with manufacturing and product design teams to:
o Facilitate and create processes
o Implement systems to produce a quality and cost-effective product
o Improve Labor cycle times
• Improve existing processes for boosting productivity, quality and cost
• Assist with the preparation of proposals and quotes for customers
• Creates process risk assessments
• Assesses safety requirements ensuring they are part of the process for the builder, user and customer
• Prepares Engineering Change Orders for processes, components, and Bill of materials
• Performs and advises Corrective and Preventive Action tasks
• Other Duties as assigned
• FDA cGMP principles and practices
• Must have 3 or more years’ experience of medical device process or medical manufacturing engineering
• 2 years’ experience with bonding techniques. I.E. - Adhesives, Chemical, Laser, Resistance welding
• Familiarity with biocompatible materials
• Exposure to Pro-E / CREO and or SolidWorks preferred
• Strong computer skills associated with Microsoft software
• Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
• Possess a keen attention to detail
• Must be able to read, write and speak fluent English
• Excellent reading, writing, communication, and organizational skills
• Demonstrated ability for systematic problem solving, DMAIC
• Maintains performance with changing priorities under minimal supervision
• Must maintain high ethical standards
• Must be able to make clear and accurate decisions
• Ability to learn and apply new technology
• Must have a BS degree in relevant engineering discipline with a minimum 3 years of related engineering experience
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 63184536TT
Equal Opportunity Employer


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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