Senior Software Quality Engineer
- Compensation
- Not disclosed
- Location
- San Francisco
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 8+ years
- Category
- Industrial engineering
- Posted
Skills
Must have
- 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 differe
- Experience in navigating ambiguity, bringing clarity to complex situations and thriving in a fast-paced environment
Full 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.