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Electrical Engineer I

2 months ago

Alameda, United States Intellectt Inc Full time

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:

  • Bachelor’s 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.