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 (Possible extension)
Shift Timings: 8 am to 5 pm
100% Onsite role.
Summary
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.
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.
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 to 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. 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
Skills
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
Bachelor's degree in either Electrical or Mechanical
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
Phone Screen or video with Brian then 2nd round will be In-person meeting for local candidates and video meeting for candidates willing to relocate at own expense.
Seniority level
Mid-Senior level
Employment type
Internship
Job function
Engineering and Information Technology
Industries
Human Resources Services
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