Quality Engineering Lead

Echo Neurotechnologies; San Francisco (CA); On-site; USD 200,000 - 220,000; Full time

Benefits offered by this job

Stock options

401(k) with matching

Competitive compensation

Job summary

Echo Neurotechnologies, a startup in the Brain-Computer Interface space, seeks a Quality Engineering Lead to champion Design Assurance across hardware and software in a fast-paced, regulated environment. You will own the QMS strategy, lead V&V activities, and ensure compliance with FDA, ISO13485, IEC 62304 and ISO 14971 while mentoring a growing quality team.

You will collaborate across cross-functional teams, manage risk, coordinate supplier qualifications, and drive continuous improvement

Qualifications

• 10+ years in quality engineering or medical device development.
• Experience with FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1 in regulated environments.
• Experience with software/hardware V&V and AI/ML technology.
• Hands-on risk management with FMEA and design controls.
• Ability to collaborate across time zones and multi-disciplinary teams.

Responsibilities

• Lead and implement the QMS per FDA, ISO 13485, IEC 62304, IEC 62366-1.
• Provide quality oversight to product development files and docs.
• Lead risk management activities including FMEA.
• Collaborate with vendors and supplier qualification.
• Support audits and provide compliance evidence.
• Drive root cause analysis for nonconformances and CAPAs.
• Mentor junior team members and promote quality culture.

Skills

Quality engineering leadership

Regulatory compliance

V&V for software/hardware

AI/ML experience

FMEA / risk analysis

Cross-functional collaboration

Regulatory documentation

Education

Bachelor’s or Master’s degree in Engineering

Tools

eQMS tools

FMEA tools

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.

Position Overview:

As the Quality Engineering Lead, you will partner with the cross-functional team to act as a champion of Design Assurance and Quality 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 requiring deep experience in design controls, risk management, design verification and validation, and regulatory submissions. As a Quality Engineering lead, you will be building scalable quality systems while directly executing critical quality engineering activities. You will support multiple domains at the system level across hardware and software engineering, supplier quality and quality system implementation.

Primary Duties & Responsibilities:

• Lead and strategize ongoing implementation of the Quality Management System (QMS) in conformance with US FDA Quality System Regulations, ISO 13485, IEC 62304 and IEC 62366-1 and other relevant standards
• Provide quality oversight and support to the product development team in creation of design and development files (DDFs) including product requirements, software and hardware design specifications, design verification test protocols and reports, risk management file, cybersecurity risk files, biocompatibility and sterilization validation deliverables, traceability matrices, etc.
• Guide and lead risk management activities, including failure modes and effects analysis (FMEA) and hazards analysis, in alignment with ISO 14971
• Engage and collaborate with vendors and participate in assessing supplier qualifications
• Support and participate in internal and external audits, coordinating and providing documentation and evidence of compliance
• Lead root cause analysis for nonconformances, defects and CAPAs, issue management, management review and quality data analysis
• Mentor junior quality team members and provide quality leadership on projects
• 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, Mechanical, Electrical, or related field).
• 10+ 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 and hardware V&V activities, experience with AI/ML technology
• 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

$200,000 - $220,000 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.

Confidentiality

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