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Sr Process Development Engineer - 53246637 - JA

Job Code: 53246637
Job Location: Plymouth, MN
Category: Mechanical Engineering
Last Updated: 10/25/2016
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Job Description:
Senior Process Development Engineer  
• Plans and coordinates the execution of process characterization and validation
• Successfully complete all the Process Development Engineering elements of the PDP by the milestone dates
• Work with drafting and documentation departments to create all required documents (manufacturing processes, drawings, protocols, reports, etc.)
• Ensures process capability and yield targets are met
• Provide mentoring and direction to more junior technical staff
• Hands-on development of manufacturing processes
• Present status of plans and projects to larger team.
• Develop requirements and procure equipment for manufacturing processes
• Lead small team(s) for process development or problem solving
Minimum Qualifications-  
• BS degree (Mechanical, or related technical field) with 5 years’ experience
• Good verbal and written communication skills
• Good presentation skills
• Leadership and self-starter qualities
• Experience developing and validating medical device manufacturing processes (IQ, OQ, PQ, and PPQ)
• Working knowledge of PFMECAs, sampling plans, normality assessment, and capability assessment
• Process validation protocol and report writing
• Demonstrated problem solving skills
• History of successfully transferring projects to manufacturing
• Excel and Word skills
Preferred Qualifications
• MS degree (Mechanical, or related technical field) with 10 years’ experience
• Six Sigma training; Minitab and Design Expert skills (DOE and other statistical analysis)
• Stent or balloon catheter manufacturing experience
• Experience with polymer extrusion, thermal bonding, and adhesive bonding
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 53246637JA
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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