Electrical Engineer I

Role: Electrical Engineer I (Medical Device)
Location: Alameda, CA
Duration: 06 Months
Job Summary: We are seeking a skilled Electrical Engineer with experience in qualifying alternate electronic and mechanical components for medical products. The ideal candidate will have a strong focus on tasks rather than titles and will take on a lead role in this project, working independently to ensure comprehensive technical assessments and documentation. This role involves close collaboration with R&D, Quality Assurance, Regulatory, Operations, and Global Sourcing teams.
Key Responsibilities: Review and qualify alternate electronic and mechanical components based on recommendations. Create change impact documentation with technical assessments to justify changes, ensuring accuracy and comprehensiveness. Lead cross-functional teams in reviewing documentation and supporting organizational goals. Act as a Subject Matter Expert (SME) or Independent Technical Expert (ITE) on project technical matters, interfacing with senior management and external agencies. Ensure timely completion of documentation in accordance with business standards. Adhere to applicable EHS policies, procedures, and regulations, as well as corporate and divisional GMP standards. Required Qualifications: Bachelors degree in electrical engineering (required). 5+ years of real work experience in the medical device industry (internships, co-ops, and school projects will not be considered). Experience with cGMP, FDA, and ISO13485 regulations. Strong understanding of general engineering principles, particularly in medical device design and manufacturing. Excellent written and verbal communication skills, with a patient and thorough approach.