Design Quality Engineer - Fully Remote/Off-site

Starts Ready to hire
Duration 6+ Months
Status Freelance (40 hours a week)
Rate $55/hr. - $70/hr. (DOE)
The Bay Area's best-known search engine giant is seeking a Design Quality Engineer to assist their team.

Top Responsibilities:
-Provide for ongoing review of design control activities to ensure that all procedures guiding the processes and outputs of these processes meet applicable regulations and standards.
-Propose, review and approve proposed changes to design control and software management policies and procedures that are a part of the Company’s Quality Management System
-Participate as a peer with design and development engineers on complex technical topics to ensure design solutions are compliant with company procedures, adequately mitigate safety risks, and are likely to be acceptable to regulatory product reviewers (if applicable).

Ideal Qualifications:
-Bachelor’s degree in engineering, technology or science related field. Preferred degrees include BSCS, BSCE, BSBE
-5+ years’ of software design assurance or quality engineering experience in the medical device industry including direct experience with software regulated as a medical device in the United States and European markets.
-5+ years’ of experience in performing Risk Management activities under ISO 14971 or equivalent risk management frameworks. This must include hands-on experience performing Hazards Analysis, FTA, DFMEA and UFMEA.
-Significant experience in developing software engineering documents as components of a Design History File including; Design and Development Plans, Design Inputs and Outputs, Verification and Validation protocols and reports, Design Transfer Plans, Design Review Minutes, Risk Management Plans, Risk Analyses.

Submit resume (and samples if applicable) to: