Senior Process Development Engineer

Job Title: Senior Process Development Engineer

Job location: Plymouth MN

Duration: 12+months (Possibility of extension)

Responsibilities

·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.