Design Controls Engineer Consultant I

Position
Design Controls Engineer Consultant I
Location: Minneapolis MN
Duration: 8 months
 
Description:
 
What You Will Do: 
• You will be supporting R&D integration efforts, including the deployment of the Product Development, Launch and Maintenance (PDLM) process and the Windchill Product Lifecycle Management (PLM) software. 
• Activities include comparative assessments of current state to PDLM, working with functional Subject Matter Experts (SME’s) to develop adoption plans, revising documents, conducting document reviews and executing Engineering Change Orders. 
 
What Success Looks Like: 
• Independently compare current state processes to PDLM process and recommend adoption plans. 
• Ability to collaborate with SME’s across functions, across sites and at different levels of the organization. 
• Drafting documents based SME direction that incorporate PDLM framework into functional procedures. 
• Contributes critical thinking to create robust documentation, identifies where interdependencies between functions exist and elevates to appropriate SME’s and Project Manager. 
• Able to lead change reviews and accurately capture and address input from reviewers to maximize first time approval of Engineering Change Orders. 
• Coordinating training to support release of new documents and processes. 
• Can manage and prioritize a large number of concurrent and independent tasks. 
• Ability to take direction from multiple sources and accomplish tasks independently. 
• Tracks and reports progress, will communicate any identified risks or delays to projects. 
 
Desired Experience: 
• B.S. of Mechanical, Chemical, Industrial, Materials or Biomedical Engineering or similar field 
• 2-5 years of experience working in product development of Medical Devices. 
• Familiar with Design Controls processes, including cross-functional development activities. 
• Technical writing experience, including writing procedures, creating templates for project deliverables and documenting supporting rationale. 
• Leading implementation of changes including document review, Engineering Change Orders, and coordination of training. 
• Experience with MS Work, MS Excel and MS PowerPoint. 

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