Senior Software Quality Engineer
Echo Neurotechnologies
$155,000 - $185,000 / year
Need a reasonable accommodation to apply or interview? Contact us.
JobMinglr uses automated technology to recommend jobs based on profile information and job preferences. Match Score does not determine eligibility for a position, prevent a user from viewing or applying to a job, or make hiring decisions on behalf of an employer.
Description
Company Overview
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
- Foster a collaborative environment, champion conti
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
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.
Benefits
- 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.
About this role
Echo Neurotechnologies is seeking a Senior Software Quality Engineer to establish and maintain rigorous quality standards across their brain-computer interface product development. This is a hands-on role at an early-stage startup where you'll own quality assurance across the full product lifecycle—from design through production—working directly with hardware engineers, software developers, and suppliers. You'll be responsible for implementing their Quality Management System in compliance with FDA, ISO 13485, IEC 62304, and related medical device regulations, and for building the documentation infrastructure (design history files, traceability matrices, risk assessments) that regulatory bodies require.
The role demands deep expertise in medical device quality and regulatory frameworks. You'll need at least eight years of experience in quality engineering or medical device development, with demonstrated proficiency in design controls, software verification and validation, risk management tools like FMEA, and work in regulated environments. Experience with AI/ML technology is valued but not required. Beyond technical knowledge, you'll guide cross-functional teams through risk management and root cause analysis, lead internal and external audits, and communicate complex compliance requirements to both technical teams and regulatory bodies.
This position suits someone who thrives in ambiguity and wants meaningful impact early in a company's trajectory. The in-office San Francisco role offers competitive compensation ($155,000–$185,000), stock options, and comprehensive benefits, alongside the opportunity to shape quality practices at a startup focused on restoring autonomy to people with disabilities.
How this employer is doing
average
- Sponsors Visas
This role's local market on JobMinglr
Pay for this role
$155,000 to $185,000 per year
That is the employer's posted range, and where you land in it is usually decided in one conversation. Before that conversation, run the numbers: analyze an offer for this role.
Before you apply, worth reading
How JobMinglr reads this job
Every listing here is scored against your profile before you apply: skills overlap, experience level, location and work arrangement, each weighted and explained. You see the score and the reasons, not just a list. How the matching works.