Sr. Software Quality Engineer
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.
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 Duties & 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 continuous improvement initiatives and promote a quality culture across the organization
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.
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 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
Skills and Abilities:
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
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.
Comprehensive benefits package.
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.