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R-D Engineer III

Lancesoft Inc
Plymouth, Minnesota, United States
December 02, 2016

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 transfering 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