Supplier Quality Engineer

Echo Neurotechnologies; San Francisco (CA); On-site; USD 136,000 - 170,000; Full time

Benefits offered by this job

Stock options

401(k) matching contributions

Job summary

Echo Neurotechnologies in San Francisco, CA is seeking a Supplier Quality Engineer to partner with cross-functional teams across the product lifecycle. You will lead supplier qualification, risk management, and process validations to ensure compliance with quality systems and regulations.

This hands-on role requires experience in supplier management, risk analysis, and design transfer while supporting scalable quality systems across multiple programs.

Qualifications

• Degree in Engineering (Biomedical, Mechanical, Electrical, or related).
• 3–7 years of quality engineering or medical device development experience.
• Strong understanding of FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1 in regulated environments.
• Ability to travel up to 25%.

Responsibilities

• Identify supplier risks and support cross-functional teams to prevent issues.
• Support supplier quality activities across product development lifecycle.
• Maintain procedures to ensure compliance with regulatory standards.
• Track KPIs and metrics for Supplier Quality.

Skills

Analytical skills

Problem-solving

Regulatory awareness

Education

Bachelor’s or Master’s degree in Engineering

Tools

FMEA

Risk analysis

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 the Supplier Quality Engineer, you will report to the Supplier Quality Manager and partner with cross-functional teams to execute critical Supplier Quality activities throughout the product development lifecycle. You will ensure that your work meets the highest quality standards and complies with all applicable compliance standards and regulations. This is a hands‑on role requiring experience in supplier management, risk management, manufacturing line bring ups, and design transfer. As a Supplier Quality Engineer, you will directly support the development of scalable quality systems by executing vital quality engineering activities across multiple programs.

PRIMARY ROLE AND RESPONSIBILITIES

• Support the selection, evaluation and monitoring of suppliers and assist in maintaining the Approved Supplier List (ASL)
• Work with suppliers and the Supplier Quality Manager to ensure quality agreement and technical expectations are met
• Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity
• Assist in maintaining procedures to ensure that the organization complies with applicable regulatory standards
• Support suppliers and the technical team through key activities such as process FMEAs, manufacturing flow and control plans, master validation plans, process validation (IQ/OQ/PQ), and equipment qualifications
• Work with the Engineering and Operations teams to establish manufacturing test specifications, critical to quality specifications, and inspection criteria
• Participate and provide engineering input at Material Review Board (MRB) meetings
• Track and report on defined KPIs and metrics for Supplier Quality
• Support internal and external audits by coordinating and providing documentation and evidence of compliance
• Foster a collaborative environment, support 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).
• 3 – 7 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
• Ability to travel up to 25% of the time
• Prior experience in product / manufacturing line transfers
• Hands‑on experience with risk management tools (e.g. FMEA, risk analysis)
• 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

$136,000 - $170,000 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.