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 MBEย |GSA - Schedule 66ย Iย GSA - Schedule 621I
DIRECT # -ย 732-844-8724
LinkedIn:ย https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified ย for Health Care Staffing
"INCย 5000'sย FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)