Sr. Quality Engineer

Echo Neurotechnologies • San Francisco, CA

141d

About The Position

As a Sr. 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 hardware and software engineering, supplier quality and quality system implementation.

Requirements

• Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Mechanical, 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, IEC 60601) and experience working in a regulated environment
• Experience with software and hardware 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 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

Nice To Haves

• Experience with AI/ML technology

Responsibilities

• Participate in ongoing implementation of the Quality Management System (QMS) in conformance with US FDA Quality System Regulations, ISO 13485, IEC 62304, IEC 60601 and IEC 62366-1 and other relevant standards
• Support the product development team in creation of design history files (DHF) including product requirements, software and hardware design specifications, design verification and validation 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 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 continuous improvement initiatives and promote a quality culture across the organization

Benefits

• 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

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree