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Electrical Engineer

3 months ago

Alameda, United States ICONMA Full time

Participates on engineering teams in completing development projects.

Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.
Leads small-scale design change efforts in support of continuation engineering activities.
Completes system, analog, digital, and firmware designs.
This includes setting and revising requirements and specifications, debugging, testing electrical circuits and systems, and completing documentation to ensure feasibility and verifiability of performance.
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.

Requirements:

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.
Extensive understanding of processes used in the design and manufacturing of medical devices, particularly handheld devices.

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard trace, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Vimal Kumar

M: (XXX) XXX-XXXX