Noah Medical
Staff Design Assurance Quality Engineer- Software
Noah Medical, San Carlos, California, United States, 94071
Overview
Staff Design Assurance Quality Engineer- Software Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members to revolutionize robotic surgery. Our Quality team drives innovation, product leadership, and adherence to FDA and international regulatory standards, with an emphasis on agile quality management systems and continuous improvement. This is a Full Time Salaried position. Role and Responsibilities
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. Review software-related verification and validation strategy for the R&D organization and ensure compliance with the strategy execution. 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 on 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 modifications and tracking related to software upgrades. Review root cause analyses of identified design issues and identify appropriate corrective and preventive actions (use NC and CAPA systems as needed). May perform audits of Design History Files and support internal and external audits. Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries. Partner with PMO to apply project management tools to define project deliverables and establish a project schedule. Work collaboratively in a fast-paced environment with minimal supervision and guidance. Maintain trained status for and comply with Noah Medical Quality Management System to ensure product and regulatory compliance. As the voice of quality, apply and promote best-practice use of statistical tools and techniques throughout the organization. Other QMS activities as assigned. About You
BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related programs. Minimum of 8 years of Engineering work experience with a BS or a minimum of 5 years 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 environment. 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 requirements with emphasis on IEC 62304. Experience with Risk Management, FMEA, Hazard Analysis. Experience with 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. Passionate about SW and technologies for healthcare. #LI-Hybrid Pay Transparency
The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives. $139,200 - $175,000 USD Benefits & Perks (For Full Time Employees)
Comprehensive health insurance including Medical, Dental and Vision + 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 + sick time Paid parental leave In-office snacks and beverages Learning & Development Opportunities: On-demand online training and book reimbursement Team building and company organized social and celebration events Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable. Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws. Important Notes
NO AGENCIES PLEASE - Please do not outreach to any managers or submit resumes without a signed agreement from Talent Acquisition. Resumes shared without a signed agreement will be considered your gift to Noah Medical and no fee will be paid.
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Staff Design Assurance Quality Engineer- Software Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members to revolutionize robotic surgery. Our Quality team drives innovation, product leadership, and adherence to FDA and international regulatory standards, with an emphasis on agile quality management systems and continuous improvement. This is a Full Time Salaried position. Role and Responsibilities
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. Review software-related verification and validation strategy for the R&D organization and ensure compliance with the strategy execution. 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 on 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 modifications and tracking related to software upgrades. Review root cause analyses of identified design issues and identify appropriate corrective and preventive actions (use NC and CAPA systems as needed). May perform audits of Design History Files and support internal and external audits. Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries. Partner with PMO to apply project management tools to define project deliverables and establish a project schedule. Work collaboratively in a fast-paced environment with minimal supervision and guidance. Maintain trained status for and comply with Noah Medical Quality Management System to ensure product and regulatory compliance. As the voice of quality, apply and promote best-practice use of statistical tools and techniques throughout the organization. Other QMS activities as assigned. About You
BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related programs. Minimum of 8 years of Engineering work experience with a BS or a minimum of 5 years 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 environment. 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 requirements with emphasis on IEC 62304. Experience with Risk Management, FMEA, Hazard Analysis. Experience with 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. Passionate about SW and technologies for healthcare. #LI-Hybrid Pay Transparency
The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives. $139,200 - $175,000 USD Benefits & Perks (For Full Time Employees)
Comprehensive health insurance including Medical, Dental and Vision + 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 + sick time Paid parental leave In-office snacks and beverages Learning & Development Opportunities: On-demand online training and book reimbursement Team building and company organized social and celebration events Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable. Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws. Important Notes
NO AGENCIES PLEASE - Please do not outreach to any managers or submit resumes without a signed agreement from Talent Acquisition. Resumes shared without a signed agreement will be considered your gift to Noah Medical and no fee will be paid.
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