Staff Design Assurance Quality Engineer- Software 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, Healthcare, RoboticsIndustries

Requirements

BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related programs
Minimum of 8 years of Engineering work experience with a BS or a minimum of 5 years of Engineering work experience with a PhD in the medical device or similarly regulated industry

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 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 to structure activities
May 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, apply and promote best-practice use of statistical tools and techniques throughout the organization
Other QMS activities not specified here and as assigned

Skills

Design Assurance

Quality Engineering

Software Quality

FDA Compliance

Regulatory Standards

Design Requirements

Design Specifications

Design Verification

Product Development

Medical Devices

Risk Management

Agile Quality Systems

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

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Mental Health Support

Legal Services

Pet Insurance

12+ Paid Holidays

15-20 Days of PTO

Paid Parental Leave

In-office Snacks and Beverages

In-office Lunch Stipend

Learning & Development Opportunities

Team Building and Company Organized Social Events

Hybrid Work Options

Risks

Increased competition from established companies like Intuitive Surgical in robotic bronchoscopy.

Potential delays in regulatory approvals could impact market entry and sales.

High cost of the Galaxy System™ may limit adoption in smaller healthcare facilities.

Differentiation

Noah Medical's Galaxy System™ offers real-time navigation updates for lung procedures.

The system's single-use bronchoscope reduces cross-contamination and improves procedural efficiency.

Compact design of the Galaxy System™ suits crowded bronch suites and operating rooms.

Upsides

Growing demand for minimally invasive procedures aligns with Noah Medical's focus.

Rising investment in healthcare technology startups offers funding opportunities for Noah Medical.

Advancements in AI enhance real-time image processing in Noah Medical's robotic systems.

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