Sr. Software Quality Engineer

Echo; San Francisco (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation, including stock options

Comprehensive benefits package

401(k) program with matching contributions

Job summary

Echo is seeking a Sr. Software Quality Engineer to champion Design Quality Assurance throughout the product development lifecycle. You will lead risk management activities and ensure compliance with FDA and ISO regulations.

The ideal candidate has 8+ years of quality engineering experience in medical devices and a strong understanding of the relevant standards. This role offers competitive compensation, stock options, and a collaborative work environment.

Qualifications

• 8+ years of quality engineering or medical device development.
• Strong understanding of medical device regulations (FDA, ISO 13485, etc.).
• Experience with software V&V activities is a plus.

Responsibilities

• Implement Quality Management System in compliance with relevant standards.
• Support product development in creating design history files.
• Guide risk management activities including FMEA.

Skills

Working in eQMS tools

Written and verbal communication

Analytical skills

Problem-solving skills

Organizational skills

Education

Bachelor’s or Master’s degree in Engineering

Job description

Sr. Software Quality Engineer

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 Duties & 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
• Foster a collaborative environment, champion continuous improvement initiatives and promote a quality culture across the organization

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

Skills and Abilities:

• 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

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.
• Comprehensive benefits package.
• 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.

Confidentiality

All applications will be treated confidentially. Applicants may be asked to sign an NDA after the initial stages of the interview process.