Development Process Engineer / Process Validation Engineer (IQ/OQ/PQ) in Saint Paul, MN

100% onsite role

There are 2 openings for this role (Both projects are very similar and work is also similar)

Local candidates only

• Process validations, equipment qualifications, writing procedures, testing samples, writing reports, etc.
• Work with vendors for materials and equipment
• Focused on delivery systems (systems used to deliver implants to the heart) will be working on the Reflow, Tipping, and Curving processes
• Process development engineers work closely with R&D, develop processes, settings and qualify equipment
• 3+ years’ experience with hands on experience working with equipment, training operators, etc. (prefers 5+ years' experience)

Focused on delivery systems (develop process for systems that are used for heart implants)

• Pharma manufacturing process and process development individuals will not work for this role
• Medical device industry strongly preferred
• Solidworks exp (Plus) (Designing and tooling fixtures)  (Bonus)
• Some exp in root cause analysis (problem solving)
• Some one who as process ownership
• Experience in writing and executing validation not just reading and receiving validation
• Some one who has worked on production line
• working with operators and training them on process
• 3 yrs exp minimum needed
• Will be testing samples
• process Validation experience
• work closely with R&D
• Candidate will procure equipment's develop processes & develop equipment's
• equipment qualification experience
• Work on writing reports
• Hands on working on equipment's
• 5 yrs preferred exp
• Some one who has worked in clean room environment
• Exp writing manufacturing procedures
• Minitab exp
• Design for manufacturability (DFM) exp (Bonus)
• Exp working with moulding (Plastic injection moulding in general) (Bonus)
• Manufacturing operations background needed
• Automotive industry exp will also work

Work on Delivery systems

• curving
• Reflow
• Chipping
• Moulding (Bonus)

Top skills

• Exp with IQ OQ PQ
• Process Validation
• Moulding process (Bonus)
• Work with vendors ordering materials and equipment's

Education

Bachelor’s degree in mechanical or biomedical or chemical engineering

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