Electrical Engineer
Electrical Engineer
TekOne IT Services Pvt. Ltd.
Alameda, CA
See who TekOne IT Services Pvt. Ltd. has hired for this role
Skills Looking For
- Component Engineer; senior level role.
- 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.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Engineering and Information Technology -
Industries
Human Resources Services
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