Electrical Engineer - Medical Devices - Intellectt INC

Role: Electrical Engineer I
Location: Alameda, CA - 94502
Duration: 12 Months
Shift Timings: 8 am to 5 pm

Job Description:

Required Skills:

Bachelor's degree in Electrical Engineering.

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

Job 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