What are the responsibilities and job description for the Electrical Engineer position at TekOne IT Services Pvt. Ltd.?
Job Title: Electrical Engineer I
Location: Alameda, CA - 94502
Duration: 12 Months (with potential for extension)
Responsibilities
Location: Alameda, CA - 94502
Duration: 12 Months (with potential for extension)
Responsibilities
- Review technical specification sheets and qualify alternate electronic and mechanical components.
- Lead and coordinate cross-functional teams, ensuring collaboration with internal and external stakeholders.
- Provide technical assessments for recommended alternate parts and create supporting documentation.
- Communicate findings and lead review sessions with teams from Regulatory, R&D, Quality, and Operations.
- Ensure timely documentation and compliance with corporate policies, GMP, and business standards.
- Serve as a subject matter expert (SME) for electrical engineering matters related to medical products.
- Follow up on feedback and approvals from reviewers.
- Support the company’s business and clinical goals through project work.
- Education: Bachelor’s degree in Electrical Engineering (mandatory, other degrees will not be considered).
- Experience: Minimum of 5 years in the medical device industry. Internships, co-ops, and school projects will not be considered.
- Regulatory Knowledge: Hands-on experience with cGMP, FDA, and ISO13485 standards.
- Skills:
- Strong knowledge of engineering principles, particularly in the design and manufacturing of handheld medical devices.
- Exceptional written and verbal communication skills.
- Experience working within cross-functional teams and collaborating with internal departments.
- Familiarity with electrical testing tools such as oscilloscopes.
- Component Testing: Mostly off-the-shelf components (75%), with 25% requiring customized solutions and hands-on testing.
- Tools & Documentation: Experience reviewing datasheets and schematics, and working with hands-on tools.
- Interview Process: Initial phone/video screen with Brian Wu, followed by in-person/video interviews for local and relocating candidates.
- Electrical Engineering degree.
- 5 years of experience in the medical device industry.
- FDA/ISO13485 experience.
