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Staff Design Assurance Quality Engineer- Software

4 months ago

San Carlos, United States Tangerine Search, Inc. Full time

About The Team: Join our Quality team at a pioneering medical technology startup with FDA approval, where you'll be instrumental in advancing innovation and product excellence in medical robotics. We're a proactive, technically adept, and solution-focused team, actively seeking individuals who share our passion. Employing a data-centric approach, we confront challenges head-on to drive innovation. Dedicated to surpassing FDA and international regulatory standards, we take proactive steps, streamline processes, and adopt dynamic quality management systems to foster ongoing enhancement. Our primary objective is to create a significant impact on patient care by setting new standards and overcoming obstacles in the realm of medical robotics. Join us as we collectively shape the future This role offers hands-on technical leadership and guidance from a Quality standpoint across all phases of product development, including technology transfer and commercialization. We're seeking a highly motivated and solution-driven individual who can take initiative, foster teamwork, and communicate effectively. This is a full-time salaried position. A Day In The Life Of Our Staff DQA Software Engineer: * Provide hands-on guidance for defining product and system design requirements, specifications, detailed designs, and planning documentation. * Gain insights into clinical applications, workflows, and user requirements. * Develop strategies for software-related verification and validation within the R&D organization and ensure their implementation. * Act as a technical resource for risk management activities related to software, ensuring compliance with relevant standards. * Create test plans and cases based on product and component requirements. * Collaborate with Human Factors experts and R&D to evaluate software usability throughout design and development. * Review and approve maintenance of V&V systems, including modifications and tracking related to software upgrades. * Conduct root cause analysis of design issues and implement corrective and preventive actions as necessary. * Participate in audits of Design History Files and support internal and external audit processes. * Assist Regulatory Affairs with relevant submissions, approvals, and inquiries. * Collaborate with the Project Management Office to define project deliverables and establish schedules. * Work efficiently in a fast-paced environment with minimal supervision. * Ensure compliance with Noah Medical's Quality Management System to support regulatory compliance. * Promote best practices in statistical tools and techniques throughout the organization. * Engage in other Quality Management System activities as assigned. About You: * Bachelor's degree in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related fields. * Minimum of 8 years of Quality Engineering experience in the medical device field, including complex medical devices. * Minimum of 3 years' experience in a development QE function. * Experience in meeting Design Control and Design History File requirements with New Product Development teams. * Proficient in the entire Quality Management System to meet US FDA and ISO/MDR requirements, with expertise in IEC 62304. * Experience with Risk Management, FMEA, and Hazard Analysis. * Strong statistical skills for test sample size determination and data analysis techniques. * Proficiency in Microsoft Office, Google Suite, JIRA, Jama, and ePLM/eQMS systems. * Self-starter with team-building skills and excellent verbal and written communication abilities. * Passionate about software and healthcare technologies. Workplace Type: Hybrid Benefits & Perks (For Full-Time Employees): * Competitive Salary * Comprehensive health insurance including Medical, Dental, and Vision, plus HSA and FSA options * Equity & Bonus Program * Life Insurance (company-paid & supplemental) and Disability insurance * Mental health support through medical insurance programs * Legal and Pet Insurance * 12+ paid holidays, 15-20 days of PTO, plus use-what-you-need sick days * Paid parental leave * In-office snacks and beverages * In-office lunch stipend * Learning & Development Opportunities: On-demand online training and book reimbursement * Team-building and company-organized social and celebration events

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