Senior Supplier Engineer - External Manufacturing

- Mid Level

Hybrid - Arden Hills, MN

Merchant Wholesalers, Durable Goods

About the position

As part of the Sourced Finished Medical Device (SFMD) team, the Sr. Supplier Engineer is responsible for supporting the daily operations of assigned key SFMD suppliers, while driving improvements to ensure product quality and delivery. The incumbent will support the design, development, and qualification/validation strategies as well as manufacturing processes, equipment, and systems to meet manufacturing delivery goals.

Responsibilities

• Managing projects for sustaining and new production equipment, process improvements, cost reduction initiatives, and new product onboarding
• Collaborating with SFMD suppliers on current products and new product development activities including process development, validation, capacity analysis and capability studies; conduct process risk reviews
• Reviewing and managing supplier change requests through the Supplier Change Impact Assessment (SCIA); drive change notice and approval processes
• Troubleshooting issues related to the designs, materials or processes of new and existing products
• Analyzing test results to provide summarized reports and documentation on findings; make recommendations to the technical teams and leadership
• Leading and collaborating with cross-functional teams such as R&D and process development to ensure project success; support value improvement projects (VIP)
• Qualification activities through the design and coordination of engineering tests and experiments including DOE; review and provide feedback on SFMD supplier IQ/OQ/PQ, test method validations, and PFMEA
• Providing onsite training and guidance to SFMD supplier operators and technicians as needed

Requirements

• Bachelor's Degree in any engineering discipline
• 5+ years of working within manufacturing and/or process development
• Experience working in medical device or similarly regulated industry
• Strong technical acumen and decision-making skills; ability to solve problems and implement solutions
• Experience leading and influencing internal and external teams to drive results
• Ability to work independently and collaborate with cross-functional teams to complete projects and tasks
• Able to travel 25% - domestic and international

Nice-to-haves

• Experience with Supply Chain and/or Supplier Relationship Management
• Strong interpersonal skills with ability to communicate effectively with individuals on all levels
• Process and Test method Validation (IQ, OQ, PQ, TMV)
• Strong Good Documentation Practice experience
• Detail-oriented with strong organizational skills; ability to multi-task and manage competing priorities effectively

Benefits

• Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements)
• Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements)