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.

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732-844-8724

LinkedIn: https://in.linkedin.com/in/seemachawhan
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