Electrical Engineer - Medical - W2 only
Location
Alameda, CA | United States
Job description
Role: Electrical Engineer
Location: Alameda, CA - 94502
Duration: 12 Months on W2 (Possible extension)
Shift Timings: 8 am to 5 pm
100% Onsite role.
Summary
- Works independently (or in a lead role) on qualifying alternate electronic and mechanical components for medical products.
- Exercises independent judgment in reviewing technical specification sheets for alternate parts recommended by Corporate or TPMs, creating change impact documentation with technical assessment to provide reason and justification to support change, working closely with R&D to ensure technical assessment are comprehensive and accurate, and leading reviews of the documentation with cross-functional team consists of Regulatory, Quality Assurance, R&D, Operations, and Global Sourcing, Develops networks involving cross functional/cross departmental groups as well as communication to senior management.
- Looking for alternate components, reviewing specification sheets, preparing documentation explaining why this component needs to be replaced and how the new product is more feasible and the best choice.
Top Skills:
Electrical engineering degree
2 years of experience. in Med device exp ; FDA and ISO13485.
Skills Looking For:
- Component Engineer; senior level role.
- Lead role that works independently in qualifying alternate electronic and mechanical components for medical products.
- Will use independent judgment to review technical specification sheets based on recommendations and qualify alternate electronic and mechanical components based on recommendations.
- Prepare a change document in the system providing a technical assessment of why alternate products could be used with justifications supporting the change.
- Leading the review of the document they prepared with cross-functional teams such as Quality Assurance, Regulatory, R&D, and Operations.
- Good knowledge of general Engineering principles
- Familiarity with cGMP, FDA, and ISO13485 regulated environment.
- Med device exp required.
Required:
- Bachelor's degree in either Electrical or Mechanical Engineering ~ Manager not interested in other degrees
- 5+ minimum years of real work experience. Internships, Co-ops, school projects will not be considered.
- Experience and knowledge of cGMP, FDA and ISO13485
- Medical Device regulatory experience required. No other regulatory experience will be considered.
- Excellent written and verbal communication skills
- Extensive understanding of processes used in the design and manufacturing of medical devices, particularly handheld devices
Duties
- 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
- 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 to 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.
- Other tasks and duties as assigned.
- Understand and comply with applicable EHS policies, procedures, rules and regulations.
- Responsible for compliance with applicable Corporate and divisional policies, GMP and performing duties as assigned by management
Education and Experience:
- Bachelor in Engineering degree (Electrical or Mechanical only).
- A minimum of 2 years of experience is needed.
Job tags
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