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About the Role

Drive end-to-end documentation and process rigor across Class III medical device software products, supporting clinical trials and commercialization. This role ensures software is safe, effective, compliant, and ready for market by bridging software engineering, quality systems, and regulatory compliance.

Responsibilities

• Work alongside software engineers to author, review, and maintain design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
• Ensure software development processes align with IEC 62304, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Author and maintain software risk management files, including Software FMEAs per ISO 14971.
• Produce software verification and validation (V&V) protocols and reports in coordination with engineering and test teams.
• Compile and organize necessary software technical documentation for regulatory submissions.
• Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.

Requirements

• 5+ years of experience in the medical device industry, specifically working with software-driven or connected medical devices (Class II or Class III).
• Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience.
• Demonstrated experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
• Proven track record of taking a medical device software product through a successful FDA clearance/approval process and subsequent launch.
• Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines.
• Experience with modern software development workflows (e.g. Git, Jira).
• Experience with quality system tools (e.g. Greenlight Guru, Arena, Matrix Requirements, or Jama).
• Experience maintaining medical device software post-launch, including managing software changes and compliance updates.

Skills

• Software Design Controls
• IEC 62304
• ISO 13485
• FDA 21 CFR Part 820
• Risk Management
• ISO 14971
• Verification and Validation (V&V)
• Regulatory Submission
• Post-Market Surveillance
• CAPA Management
• Git
• Jira
• Greenlight Guru
• Arena
• Matrix Requirements
• Jama

Location

• Remote

Work Type

• Full-time

Experience Level

• 5+ years

Education Level

• Bachelor's degree

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.