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Electrical Engineer
3 months ago
Location: Alameda, CA 94502
Duration: 12 Months
Description:
- Require Electrical Engineering degree and experience related to qualifying alternate electronic and mechanical components for medical products.
- This candidate will be working in a lead role. 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.
Required:
* Bachelor's degree in Electrical 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
* Good knowledge of general Engineering principles
* Medical Device regulatory experience required. No other regulatory experience will be considered.
* Excellent written and verbal communication skills, and plenty of patience. These are essential
* 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 and clinical needs as they relate to projects.
* Lead and/or participate on cross-functional teams review and 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.
* Following up with reviewers for their feedback and approvals.
* 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
Top Skills ~ Degree, 5+ years of work exp in medical device industry., FDA / ISO13485
CPRA: The Company is committed to complying with the California Privacy Rights Act ("CPRA") effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
