Senior Electrical Engineer Location: Alameda, CA Description: + We are focusing on selecting candidate with Electrical Engineering degree and experience related to qualifying alternate electronic and mechanical components for medical products. + This candidate will be working in a lead role. Works independently (or in a lead role) on qualifying alternate electronic and mechanical components for medical products. + Review technical specification sheets based on recommendation and qualify alternate electronic and mechanical components based on recommendations. + Coordinate and lead the utilization internal/external resources to achieve project goals. + Understand the business needs of the company and have a thorough understanding of customer and clinical needs as they relate to projects. + Lead and/or participate on cross-functional teams review and support organizational goals. + Serve as subject matter expert (SME) or independent technical expert (ITE) on a project's technical matters; may interface with senior management, external firms or agencies; may coordinate technical matters between organizations. + Responsible for completing documentation in a timely manner and in accordance with business standards. + Following up with reviewers for their feedback and approvals. Required: + Bachelor’s degree in Electrical Engineering required. + 5+ minimum years of real work experience. + Experience and knowledge of cGMP, FDA and ISO13485 + Good knowledge of general Engineering principles + Medical Device regulatory experience required. + 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. As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.