Staff Design Assurance Quality Engineer – Software (Contract) at Noah Medical

San Carlos, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Robotics, HealthcareIndustries

Requirements

BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related field
Highly motivated, solution-oriented, self-starter, team builder, and excellent communicator
Ability to provide hands-on technical guidance and leadership from a Quality perspective throughout product development, technology transfer, and commercialization
Understanding of clinical applications, workflow, and user needs
Expertise in software-related verification and validation strategies compliant with relevant standards
Serves as technical resource for risk management activities for software in compliance with ISO 14971 and IEC 62304
Ability to review test plans and test cases based on product and component level requirements
Experience partnering with Human Factors SMEs and R&D to assess software usability
Capability to review and approve V&V system maintenance, reworks, modifications, and tracking for software upgrades
Proficiency in reviewing root cause analysis, identifying corrective and preventive actions, and using NC and CAPA systems
Experience performing audits of Design History Files and supporting internal/external audits
Ability to support Regulatory Affairs with submissions, approvals, requests, and inquiries
Skill in partnering with PMO to define project deliverables and establish schedules using project management tools
Ability to work collaboratively and efficiently in a fast-paced environment with minimal supervision
Maintain trained status and comply with all relevant aspects of Noah Medical Quality Management System
Promote best-practice use of statistical tools and techniques as the voice of quality

Responsibilities

Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation
Review 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 development
Review 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
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 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
Apply and promote best-practice use of statistical tools and techniques throughout the organization
Other QMS activities not specified here and as assigned

Skills

Software Quality Assurance

Design Assurance

FDA Regulations

Medical Device Regulations

Quality Management Systems

Product Development

Technology Transfer

Regulatory Compliance

Noah Medical

Develops medical robotic solutions for pulmonology

About Noah Medical

Noah Medical creates medical robotic solutions to improve early diagnosis in pulmonology. Their main product, the Galaxy System™ with TiLT+ Technology™, enhances diagnostic accuracy by providing real-time navigation and an augmented fluoro feature for locating lesions. The system is designed for efficiency with a single-use bronchoscope that reduces cross-contamination risks and improves workflow. Noah Medical stands out by collaborating with leading pulmonologists to ensure their technology meets practical clinical needs.

Redwood City, CaliforniaHeadquarters

2018Year Founded

$145.9MTotal Funding

SERIES_BCompany Stage

Robotics & Automation, HealthcareIndustries

201-500Employees