Lead role that works independently in qualifying alternate electronic and mechanical components for medical products.
Will use independent judgment to review technical specification sheets based on recommendations and qualify alternate electronic and mechanical components based on recommendations.
Prepare a change document in the system providing a technical assessment of why alternate products could be used with justifications supporting the change.
Leading the review of the document they prepared with cross-functional teams such as Quality Assurance, Regulatory, R&D, and Operations.
Good knowledge of general Engineering principles
Familiarity with cGMP, FDA, and ISO13485 regulated environment.
Med device exp required.
Day to Day: Looking for alternate components, reviewing specification sheets, preparing documentation explaining why this component needs to be replaced and how the new product is more feasible and the best choice.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Human Resources Services
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