Senior Process Development Engineer

Integrated Resources Inc.; Plymouth (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading staffing firm is seeking a Senior Process Development Engineer in Plymouth, MN for a 12+ month contract with potential for extension. The role focuses on planning and executing process validation in medical device manufacturing. Ideal candidates will have a BS in Mechanical Engineering and relevant experience in process development and manufacturing. A strong background in problem-solving and leadership is essential for mentoring junior staff and ensuring project delivery.

Qualifications

• 5 years’ experience in process development engineering.
• Experience developing and validating medical device manufacturing processes.
• History of successfully transferring projects to manufacturing.

Responsibilities

• Plans and coordinates process characterization and validation.
• Mentors junior technical staff.
• Leads small teams for process development.

Skills

Problem solving

Leadership

Communication skills

Document writing

Technical knowledge

Education

BS degree in Mechanical Engineering or related technical field

MS degree in Mechanical Engineering or related technical field

Tools

Minitab

Design Expert

Excel

Word

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 Description

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

· 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.

Additional Information

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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