Senior Software Quality Engineer — Medical Devices & QMS

Echo Neurotechnologies; San Francisco (CA); On-site; USD 155,000 - 185,000; Full time

Benefits offered by this job

Stock options

401(k) matching

Competitive compensation

Job summary

Echo Neurotechnologies in San Francisco, CA is seeking a Sr. Software Quality Engineer to champion Design Quality Assurance across the product lifecycle.

You will uphold the highest quality standards and ensure compliance with FDA QMSR, ISO 13485, IEC 62304, and ISO 14971 in a fast-paced, AI-enabled medical device environment. You will collaborate with cross-functional teams, lead risk management activities, drive DHF creation, software V&V, supplier involvement, and audits to ensure robust

Qualifications

• Bachelor’s or Master’s degree in Engineering (Biomedical, CS, Electrical, or related).
• 8+ years of quality engineering or medical device development.
• Strong understanding of medical device regulations and standards (FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1).
• Experience with software V&V; AI/ML experience a plus.
• Hands-on risk management and design controls; cross-disciplinary collaboration.
• Experience navigating ambiguity in fast-paced environments.

Responsibilities

• Participate in ongoing implementation of the QMS in conformance with US FDA QMSR, ISO 13485, IEC 62304, IEC 62366-1.
• Support DHFs creation including product requirements, software architecture and design specs, test protocols and reports.
• Guide and lead risk management activities including FMEA and hazards analysis per ISO 14971.
• Lead computerized system assurance and validation for SW tools and systems.
• Collaborate with suppliers and support design transfer activities.
• Support internal/external audits with documentation and evidence.
• Support root cause analysis for nonconformances, CAPAs and quality data analysis.

Skills

Quality engineering

Software V&V

AI/ML understanding

Regulated environment

Education

Engineering degree

Biomedical/CS/EE emphasis

Tools

eQMS software

Job description

Echo Neurotechnologies in San Francisco, CA is seeking a Sr. Software Quality Engineer to champion Design Quality Assurance across the product lifecycle.

You will uphold the highest quality standards and ensure compliance with FDA QMSR, ISO 13485, IEC 62304, and ISO 14971 in a fast-paced, AI-enabled medical device environment. You will collaborate with cross-functional teams, lead risk management activities, drive DHF creation, software V&V, supplier involvement, and audits to ensure robust