Entegee Sr Process Development Engineer - 53246637 - JA in Plymouth, Minnesota

Sr Process Development Engineer - 53246637 - JA

Job Code: 53246637Job Location: Plymouth, MNCategory: Mechanical EngineeringLast Updated: 10/17/2016Apply Now!

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 engineeringteam@entegee.com.

Please reference job # 53246637JA

Equal Opportunity Employer