Senior Process Development Engineer

IntegratedResourcesINC

Plymouth, MN, United States permanent

Posted: August 19, 2016

Quick Summary

We are seeking a Senior Process Development Engineer to join our team in Plymouth, MN. The ideal candidate will have expertise in process development and a strong understanding of IT, clinical research, and rehabilitation therapy. The successful candidate will be responsible for developing and implementing process improvements, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements.

Required Skills

Job Description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

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
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

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