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Electrical Engineer

1 month ago

Alameda, United States Collabera Full time

We are seeking a skilled and experienced Lead Component Engineer with a strong background in Electrical Engineering to qualify alternate electronic and mechanical components for medical products. The successful candidate will work independently or in a lead role, exercising independent judgment in reviewing technical specification sheets for alternate parts recommended by Corporate or Third-Party Manufacturers (TPMs). They will be responsible for creating change impact documentation with technical assessments to support changes, working closely with R&D to ensure comprehensive and accurate assessments, and leading reviews with cross-functional teams, including Regulatory, Quality Assurance, R&D, Operations, and Global Sourcing.


Key Responsibilities:

  • Component Qualification: Review technical specification sheets and qualify alternate electronic and mechanical components based on recommendations.
  • Project Coordination: Coordinate and lead the utilization of internal/external resources to achieve project goals.
  • Needs Assessment: Understand business needs and have a thorough understanding of customer and clinical needs as they relate to projects.
  • Cross-Functional Leadership: Lead and/or participate in cross-functional team reviews and support organizational goals.
  • Subject Matter Expertise: Serve as a subject matter expert (SME) or independent technical expert (ITE) on technical matters; interface with senior management, external firms, or agencies; coordinate technical matters between organizations.
  • Documentation: Responsible for completing documentation in a timely manner and in accordance with business standards, following up with reviewers for feedback and approvals.
  • Compliance: Understand and comply with applicable Environmental Health and Safety (EHS) policies, procedures, rules, and regulations; ensure compliance with applicable corporate and divisional policies, GMP, and perform duties as assigned by management.


Required Qualifications:

  • Education: Bachelor’s degree in Electrical Engineering (other degrees will not be considered).
  • Experience: Minimum of 5 years of real work experience (internships, co-ops, school projects will not be considered).
  • Regulatory Knowledge: Experience and knowledge of cGMP, FDA, and ISO13485. Medical Device regulatory experience is required.
  • Engineering Principles: Good knowledge of general engineering principles.
  • Communication Skills: Excellent written and verbal communication skills, and plenty of patience are essential.
  • Medical Devices: Extensive understanding of processes used in the design and manufacturing of medical devices, particularly handheld devices.


Preferred Skills:

  • Experience in testing electrical components, mainly off-the-shelf (75%), with 25% customized.
  • Hands-on experience with tools like oscilloscopes for 25% of tasks requiring work beyond data sheets.