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Sr. Software Quality Engineer

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Location: San Francisco Bay Area - East Bay

Purpose of Role:
• Develop and maintain all software development process related SOPs, ensuring compliance to IEC 62304:2015 and other applicable standards. • Define and maintain Risk Management, Hazard Analysis and FMEA content across the various software projects in compliance with 14971:2012. • Participate in the definition, and manage software defect review process. • Review all software development deliverables for compliance to applicable SOPs. • Project owner for the overall software project documentation plan to assign and track the various deliverables. • Reviews and modifies product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements. • Reviews and provides feedback of protocols and reports, test vendor qualification, and testing management. • Supports design verification testing and test method assessment and validation activities. • Participates in failure investigations to analyze internal system or process failures and to implement corrective and preventive action. • Audits Design History Files (DHF) and works with cross functional team to resolve documentation issues. • Identifies and implements good quality engineering practices, including statistical methods and root cause analysis tools. • Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions. • Reviews Usability and Human factors protocols and reports. Requirements: • A minimum of a Bachelor’s degree in an Engineering discipline is required. A minimum of 7 years of professional experience in a medical device manufacturing and product development environment is required. • A working knowledge of the FDA Quality System Regulation, ISO 13485:2016, ISO 14971:2012, IEC 62304:2015. IEC 60601-1 and knowledge of the EU Medical Device Directive is a plus. • The candidate must know how to apply IEC 62304 during the software development cycle. • Familiarity with test methods and standards for the design, verification, and validation of medical device products is required. • Experience in test plan development and root cause failure analysis. • Experience with Software projects, both pre and post market. • Excellent verbal (including presentation) and written communication skills, especially technical report writing, are required. The candidate must have the ability to work effectively on project teams. • Experience in complex projects involving Software and Hardware integration preferred. • Experience leading or being part of remediation activities for software products is preferred.  Good understanding of Usability and Human Factors regulations as they apply to Software products preferred. Qualified candidates please reply to: Cindy Johnson cjohnson@chozeninc.com tel: 925-577-8135


Contact Information:

E-mail: cjohnson@chozeninc.com

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Chozen, Inc. 21001 San Ramon Valley Blvd., Suite A4-147, San Ramon, CA 94583  T: 925.242.1010 F: 925.886.8600