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, Supplier Quality, and Commercial Sourcing to ensure project success; support value improvement projects (VIP)
Supporting 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 reviews
Providing onsite training and guidance to SFMD supplier operators and technicians as needed
Required qualifications
Bachelor's Degree in electrical, mechanical, or industrial engineering discipline
Minimum 5yrs 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 5% - 10% domestic and international
Preferred qualifications
Bachelor's Degree in electrical engineering
Experience with supply chain and/or supplier relationship management
Strong interpersonal skills with ability to communicate effectively with individuals on all levels
Proficient with Good Documentation Practices
Detail-oriented with strong organizational skills; ability to multi-task and manage competing priorities effectively