Staff Quality Engineer - Software

OverviewStaff Quality Engineer - Software - Design AssuranceOur client is a well funded startup company in the medical robotics space. They currently have a successful commercial product with several new exciting products in their pipeline.Target BackgroundBS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related programs.Minimum of 8 years of Engineering work experience with a BS or a minimum of 5 years of Engineering work experience with a PhD in the medical device or similarly regulated industry.Preferred: minimum of 3 years experience in a development QE function in a regulated environmentExperience in meeting Design Control and DHF requirements with NPD teams.Well versed in the complete Quality Management System to meet US FDA and ISO requirements with an emphasis on IEC 62304.Experience with Risk Management, FMEA, Hazard Analysis.Experienced in Microsoft Office, Google Suite, JIRA, Jama, and ePLM/eQMS systems.Must be a self-starter, team builder, and excellent in verbal and written communication.Preferred: experience with statistical skills to define/train on test sample size and data analysis techniques.ResponsibilitiesProvide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.Understand clinical applications, workflow and user needsReview software related verification and validation strategy for the R&D organization and ensure compliance to the execution of the strategy.Serve as a technical resource for risk management activities for software in compliance with ISO 14971 and IEC 62304.Review test plans, and test cases based upon the product and component level requirements.Partner with Human Factors SMEs and R&D to assess the usability of the software throughout design and developmentReview and approve V&V system maintenance such as reworks and modification and tracking related to software upgrades.Review root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.May perform audits of Design History Files and support both internal and external audits.Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.Work collaboratively and efficiently in a fast-paced environment with minimal supervision and guidance.Maintain trained status for and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.As the voice of quality, this role will apply and promote best-practice use of statistical tools and techniques throughout the organization.Other QMS activities not specified here and as assigned.QualificationsExperience with Design Controls and DHF in regulated environmentsFamiliarity with ISO 14971 and IEC 62304Risk management, FMEA, Hazard AnalysisStrong communication and collaboration skillsProficiency with Microsoft Office, Google Suite, JIRA, Jama, and ePLM/eQMS systemsAdditional DetailsSeniority level: Mid-Senior levelEmployment type: Full-timeJob function: Quality AssuranceIndustries: Medical Equipment Manufacturing #J-18808-Ljbffr

Created: 2025-09-18