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Job Description:
Education and Experience:
1-10 years of experience in an engineering or scientific R&D or manufacturing environment preferred.
Master's or PhD in Biomedical Engineering preferred.
Root cause analysis experience to determine the cause of issues.
Experience in the Medical Device industry - Manufacturing / Design / Quality Engineering fields- preferred.
Experience writing technical protocols/reports.
Ability to use MS Word/Excel/PowerPoint/Project.
Communicates clearly.
Speaks/writes English.
Works well with others.
Has leadership capability and is a self-starter.
Ability to learn and retain many complex processes quickly.
Focuses on detail/quality.
Roles and Responsibilities:
Work with Cataract and Vitreoretinal R&D groups on development projects resulting in achieving R&D's project goals. Tasks include supplier evaluation/qualification, component qualification, managing prototype builds, assuring the assembly process is developed and documented, ensuring BOMs are entered and maintained correctly, ensuring product costs are accurate and rolled, and conducting Production Readiness Review.
Support Product transfer projects either into or out of the plant.
Identify and qualify alternate materials and/or components for either risk mitigation or because of obsolescence.
Maintain an adequate supply of purchased components through contact with Procurement and the Suppliers. Qualify tooling and equipment as required to ensure capacity.
Address any component or product quality issue assigned, determine the root cause, and complete corrective action.
Address any requests from other departments related to BOM's and components.
Manage product labeling.
Identify and qualify Cost Improvements.
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