Description
Home Search Jobs Job Description Electrical Engineer
Contract: Alameda, California, US
Salary: $60.00 Per Hour
Job Code: 353865
End Date: 2024-10-16
Days Left: 19 days, 3 hours left
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We are seeking a highly experienced Electrical Engineer to lead and independently manage the qualification of alternate electronic and mechanical components for medical devices. This role requires a strong background in electrical engineering, medical device regulatory standards (FDA, ISO13485), and experience working with cross-functional teams. The candidate will review technical specifications, perform change impact assessments, and collaborate closely with R&D, Regulatory, and Quality Assurance teams. The focus is on tasks performed rather than job titles, making relevant hands-on experience critical.
Key Responsibilities: Lead the qualification of alternate electronic and mechanical components for medical products based on recommendations from Corporate or Third-Party Manufacturers (TPMs). Independently review technical specification sheets and perform comprehensive technical assessments to provide justification for component changes. Develop and document change impact assessments, working closely with R&D to ensure the accuracy of technical justifications. Collaborate with cross-functional teams (Regulatory, Quality Assurance, R&D, Operations, and Global Sourcing) to review and validate component changes. Serve as the Subject Matter Expert (SME) or Independent Technical Expert (ITE) on project-related technical matters. Ensure compliance with cGMP, FDA, and ISO13485 standards in all engineering and documentation tasks. Use engineering tools like oscilloscopes and schematics to review 75% of components off data sheets, while handling 25% customized components. Coordinate internal resources to meet project goals, ensuring alignment with company business needs, customer requirements, and clinical needs. Communicate effectively with senior management and external agencies when required. Complete all project-related documentation on time, adhering to corporate policies and business standards. Lead or participate in cross-functional team reviews, providing technical expertise and driving project success. Required Qualifications: Bachelor's Degree in Electrical Engineering (mandatory, no other degrees will be considered). Minimum 5+ years of hands-on experience in the medical device industry (internships, co-ops, and school projects will not be considered). In-depth knowledge of cGMP, FDA, and ISO13485 standards. Medical device regulatory experience is required; no other regulatory experience will be accepted. Strong knowledge of engineering principles, with extensive understanding of design and manufacturing processes for medical devices, particularly handheld devices. Excellent written and verbal communication skills, with a patient and detail-oriented approach. Ability to work independently and lead cross-functional teams, providing strong leadership in technical decision-making. Familiarity with using oscilloscopes and other tools to handle both off-the-shelf and custom components. Top Skills to Highlight on Resume: Electrical Engineering degree 5+ years of experience in the medical device industry Expertise in FDA and ISO13485 standards Pay Range: $50/hr to $60/hr
Job Requirement Electrical Electronic Electronics Electrical Engineering GMP ISO 13485 FDA Oscilloscopes Medical Device Reach Out to a Recruiter Recruiter Email Phone Gagandeep Singh ****** 7042475816 Apply Now