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About the Role

We are seeking a Software Design Control Engineer to 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 market-ready.

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).
• A 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) and 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
• Git
• Jira
• Greenlight Guru
• Arena
• Matrix Requirements
• Jama

Location

• Remote

Work Type

• Full-time

Experience Level

• 5+ years

Education Level

• Bachelor's degree

Salary/Compensations

• $170,000—$220,000 USD

Benefits

• Competitive compensation, including 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.