This is Tanmai from Intellect Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to tanmai@intellectt.com or call me at +1(907) 802-6640
Role: Electrical Engineer I
Location: Alameda, CA - 94502
Duration: 12 Months on W2
Shift Timings: 8am to 5pm
100% Onsite role.
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.
Day to Day: 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.
Education And Experience
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
Top Skills
Electrical engineering degree
5 years of experience.
Med device exp ; FDA and ISO13485.
Interview Process:
Phone screening followed by an onsite interview for local candidates and video for other candidates.
Seniority level
Mid-Senior level
Employment type
Internship
Job function
Engineering and Information Technology
Industries
Human Resources Services
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