Echo Labs
Sr. Software Quality Engineer
San Francisco · Senior
Sponsorship not specifiedDetected 48 days ago
Machine LearningData AnalysisHardware DesignFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingCritical ThinkingOrganizational Skills
About the role
- 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.
- Team Culture Join a small, dedicated team of knowledgeable and motivated professionals.
Responsibilities
- 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
- 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.
Requirements
- Bachelor's or Master's degree in Engineering (e.g., Biomedical, Computer Science, Electrical, or related field).
- Hands-on experience with risk management tools (e.g. FMEA, risk analysis) and design controls
- Experience in navigating ambiguity, bringing clarity to complex situations and thriving in a fast-paced environment
- 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 in establishing work relationships across multi-disciplinary teams and with partners in different time zones, building trust and demonstrating critical thinking
Nice to have
- Experience with software V&V activities, experience with AI/ML technology is a plus
Skills
- Company Overview
- Team Culture
- Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact.
- 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
- 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.
Compensation
- Competitive compensation, including stock options.
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.
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This listing is sourced directly from Echo Labs's careers page and normalized into a canonical job model.