Sr. Design Assurance Quality Engineer- Software at Noah Medical

San Carlos, California, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Robotics, Healthcare, MedTechIndustries

Requirements

BS in Engineering, Life Sciences, or related discipline
Minimum of 5 years of Engineering work experience with a BS or a minimum of 2 years of Engineering work experience 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 an emphasis on IEC 62304
Experience with Risk Management, FMEA, Hazard Analysis
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
Preferred: experience with statistical skills to define/train on test sample size and data analysis techniques
Passionate about SW and technologies for healthcare

Responsibilities

Support product development activities through application of design control processes in compliance with ISO 13485, 21 CFR 820, and IEC 62304
Participate in design reviews, risk management activities, and verification/validation planning
Review and approve test plans, protocols, and reports for design and manufacturing changes
Collaborate with R&D, Manufacturing, and Regulatory to ensure smooth design transfer and sustained product quality
Contribute to root-cause analysis, CAPA investigations, and non-conformance resolution
Assist in maintaining the Design History File (DHF) and related design documentation
Support internal and external quality audits and inspections
Provide guidance on QMS procedures, work instructions, and best practices
Monitor quality metrics, perform data analysis, and support continuous improvement initiatives
Ensure appropriate traceability and documentation of design and quality deliverables

Skills

ISO 13485

21 CFR 820

IEC 62304

Design Controls

Quality Engineering

Software Quality

Medical Device Regulations

Product Development

FDA 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

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.

Land your dream remote job 3x faster with AI

Try Jobo Free