Design Quality Engineer at Google (Fully Remote)
Position Description
MOMA Title: Design Quality Engineer
Google’s projects and products, like our users, span the globe and require quality engineering professionals to be both highly technical and familiar with global QMS requirements. As a Design Quality Engineer in the Health PA at Google, you will support development engineering to ensure the software lifecycle appropriately implements Risk Management activities and generally complies with regulatory requirements.
Role Description:
As a design quality engineer in the Google Health PA, you will help plan processes and requirements with internal customers and work hand-in-hand with your development engineering counterparts to ensure compliance with Risk Management / Design Control procedures and create the necessary documents necessary for a comprehensive Design History File. It’s your job to ensure the outputs of each phase of the design and development process are adequately planned, executed and documented in compliance with internal procedures and that a complete, compliant Risk Management strategy has been fully implemented and documented. The incumbent in this position must have detailed working knowledge of common Design Control and Risk Management models including ISO 14971,13485 and the FDA’s Quality System Regulation. Demonstrated leadership skills and ability to make risk-based decisions are core requirements.
Responsibilities
• Have direct responsibility for execution and corresponding documentation for the following elements of the design control and risk management processes:
o Risk Management Plans / Reports
o Risk Analyses (PHA, DFMEA, UFMEA)
o Risk Control
o Risk Acceptability Evaluation
o Risk Benefit Analysis
o Software Risk Classification
• 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).
• Develop and implement risk acceptability criteria as a part of the Risk Management Process.
Top 3 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).
Skill/Experience/Education
Mandatory
- 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. - Excellent written and verbal communication skills.
Desired
- Master’s degree in engineering, technology, or science related field. - Experience with cloud-based computing systems - Experience with application of risk management techniques to enterprise-level health informatics system