Senior Software Quality Engineer

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 is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting‑edge technologies that restore autonomy to people living with disabilities and improve their quality of life.

Team Culture

Join a small, dedicated team of knowledgeable and motivated professionals. Our early‑stage environment offers the opportunity to take ownership of broad decisions with significant and long‑lasting impact. We emphasize continuous learning and growth, fostering cross‑functional collaboration where your contributions are vital to our success.

SUMMARY

As a Sr. Software Quality Engineer, you will work with the cross‑functional team to act as a champion of Design Quality Assurance and Engineering activities throughout the product development lifecycle. You hold your work and teams to the highest quality standards and ensure all applicable compliance standards and regulations are met. This is a hands‑on role supporting multiple domains across system and software engineering, supplier management and quality system implementation.

PRIMARY ROLE AND RESPONSIBILITIES

• Participate in ongoing implementation of the Quality Management System (QMS) in conformance with US FDA QMSR, ISO 13485, IEC 62304, and IEC 62366‑1 and other relevant standards
• Support the product development team in creation of design history files (DHFs) including product requirements, software architecture and design specifications, design verification and validation test protocols and reports, risk management file, cybersecurity documentation, traceability matrices, etc.
• Guide and lead risk management activities, including failure modes and effects analysis (FMEA) and hazards analysis, in alignment with ISO 14971
• Guide and lead computerized system assurance and validation activities for SW tools and systems.
• Engage and collaborate with suppliers and support design, development and design transfer activities.
• Support and participate in internal and external audits, coordinating and providing documentation and evidence of compliance
• Support root cause analysis for nonconformances, defects and CAPAs, issue management, management review and quality data analysis

QUALIFICATIONS

• Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Computer Science, Electrical, or related field).
• 8+ years of quality engineering or in medical device development from concept development to production release.
• Strong understanding of medical device regulations and standards (FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366‑1) and experience working in a regulated environment
• Experience with software V&V activities, experience with AI/ML technology is a plus
• Hands‑on experience with risk management tools (e.g. FMEA, risk analysis) and design controls Experience in establishing work relationships across multi‑disciplinary teams and with partners in different time zones, building trust and demonstrating critical thinking
• Experience in navigating ambiguity, bringing clarity to complex situations and thriving in a fast‑paced environment

OTHER QUALIFICATIONS

• Proficient in working in eQMS tools with impeccable documentation skills
• Superior written and verbal communication skills to interface with cross‑functional teams and regulatory bodies
• Strong analytical skills and excellent problem‑solving skills
• Exceptional organizational skills and attention to detail

$155,000 - $185,000 USD

What We Offer

An opportunity to work on exciting, cutting‑edge projects to transform patients’ lives in a highly collaborative work environment.

Competitive compensation, including stock options.

401(k) program with matching contributions.

Equal Opportunity Employer

Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.