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Senior Electrical Engineer
3 months ago
Role: Electrical Engineer
Location: Alameda, CA - 94502
Duration: 12 Months
Requirement:
Will be working in a lead role. Works independently (or in a lead role) on qualifying alternate electronic and mechanical components for medical products. Exercises independent judgment in reviewing technical specification sheets for alternate parts recommended by Corporate or TPMs, creating change impact documentation with technical assessment to provide reason and justification to support change, working closely with R&D to ensure technical assessment are comprehensive and accurate, and leading reviews of the documentation with cross-functional team consists of Regulatory, Quality Assurance, R&D, Operations, and Global Sourcing, Develops networks involving cross functional/cross departmental groups as well as communication to senior management.
Required:
• Bachelor’s degree in Electrical Engineering ~ Manager not interested in other degrees
• 5+ minimum years of real work experience. Internships, Co-ops, school projects will not be considered.
• Experience and knowledge of cGMP, FDA and ISO13485
Good knowledge of general Engineering principles
• Medical Device regulatory experience required. No other regulatory experience will be considered.
• Excellent written and verbal communication skills, and plenty of patience. These are essential
• Extensive understanding of processes used in the design and manufacturing of medical devices, particularly handheld devices
