Manufacturing Process Engineer in Saint Paul
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Job DescriptionJob Description
Title: Process Engineer III
Job ID: 18619-1
Duration: 12+ Months Contract
Location: Maple Grove, MN
CONTRACT TO HIRE
TOP:
Medical Device experience
Process validation experience
New equipment
Inspection
Responsibilities include:
• Owning equipment, processes, inspections, development builds, and driving improvements in the associated technology and methodology
• Positioning future projects for success to continue driving Human Visual Inspection (HVI) reduction for Watchman manufacturing
• Own processes and key deliverables through DV, PV and commercial launch
• Work cross functionally and collaborate heavily with R&D, Equipment Engineering, Manufacturing Engineering, and Design Assurance to develop product concepts, equipment, inspections, influence design specifications and provide Design for Manufacturability (DFM) input to the engineering print package
• Developing new assembly and inspection capabilities for complex equipment
• Train, mentor, and/or provide work direction to engineers and technicians and may train manufacturing personnel when required as part of a validation.
• Communicating technical data and recommendations in a clear and concise manner.
• Solving complex technical problems in a hands-on manner, and working in a fast-paced, dynamic environment
• Develop, write, & review process validation strategy and related deliverables to meet quality system requirements. (e.g., Experiment tech reports, GR&R, TMV, IQ, FMEA’s, etc.)
• May serve as a core team member, workstream lead, or extended team member on new product development projects
Required qualifications:
• Bachelor’s degree in engineering or relevant technical field
• Minimum of 4 years of professional experience relevant to this role. Firm.
• Prior experience in medical device or other regulated industry
• Demonstrated cross functional collaboration and influence in a technical environment
• Experience with Automated Inspection and/or Assembly Equipment
• Demonstrated understanding of problem solving and root cause investigations
• Expertise in New Product Development and/or Operations
• Experience with Process Verification and Validation such as TMVs and OQ/PQs
• Demonstrated understanding and usage of statistics to drive improvements
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