Job Details

Client:

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

Responsibilites:

• 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.

Requirements:

• 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

Workplace Type: Hybrid