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About the Role

As a Sr. Software Quality Engineer, you will champion Design Quality Assurance and Engineering activities throughout the product development lifecycle, ensuring adherence to the highest quality and compliance standards. This hands-on role supports system and software engineering, supplier management, and quality system implementation.

Responsibilities

• Participate in the ongoing implementation of the Quality Management System (QMS) in conformance with US FDA QMSR, ISO 13485, IEC 62304, and IEC 62366-1.
• 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, and traceability matrices.
• 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 and champion continuous improvement.

Requirements

• Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Computer Science, Electrical, or related field).
• 8+ years of quality engineering or medical device development experience 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.
• 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.
• Experience in navigating ambiguity, bringing clarity to complex situations and thriving in a fast-paced environment.
• 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.

Skills

• AI/ML technology (a plus)
• Risk management tools (e.g. FMEA, risk analysis)
• Design controls
• eQMS tools
• Documentation
• Written communication
• Verbal communication
• Analytical skills
• Problem-solving skills
• Organizational skills

Location

• Remote

Work Type

• Full-time

Experience Level

• 8+ years

Education Level

• Bachelor’s degree
• Master’s degree

Salary/Compensations

• $155,000—$185,000 USD

Benefits

• Competitive compensation
• Stock options
• Comprehensive benefits package
• 401(k) program with matching contributions

About the Company

• 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.
• 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.

Equal Opportunity

• Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.