Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states.
Job Location: (Hybrid) Open to San Jose or San Carlos locations
A Day In The Life Of Our Staff DQA Software Engineer:
Provide 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 needs
Develop software-related verification and validation strategies for the R&D organization and ensure the execution of the strategies.
Serves as a technical resource for risk management activities for software in compliance with ISO 14971 and IEC 62304.
Develop 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 development
Review and approve V&V system maintenance such as reworks and modification and tracking related to software upgrades.
Perform 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.
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.
About You:
BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related programs.
Minimum of 8 years of Quality Engineering work experience in the medical device field with complex medical devices, i.e. devices that include capital hardware, disposable hardware, and software.
and a minimum of 3 years' experience in a development QE function.
Experience in meeting Design Control and DHF requirements with NPD teams.
Well versed in the complete Quality Management System to meet US FDA and ISO/MDR requirements with an emphasis on IEC 62304.
Experience with Risk Management, FMEA, Hazard Analysis.
Experienced with statistical skills to define/train on test sample size and data analysis techniques.
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: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc.
Passionate about SW and technologies for healthcare