Quality Engineering Lead, Medical Devices & BCI

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, 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