Echo Labs
Software Design Control Engineer
San Francisco
Sponsorship not specifiedDetected 14 days ago
GitProduct ManagementJiraHardware DesignClinical TrialsFDA RegulatoryMedical DevicesCollaborationWriting
About the role
- Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions.
Responsibilities
- Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
- Author and maintain software risk management files, including Software FMEAs per ISO 14971.
- Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.
Requirements
- Technical Background: A Bachelor's degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience.
- A Bachelor's degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience.
- Experience with modern software development workflows (e.g. Git, Jira) and quality system tools (e.g. Greenlight Guru, Arena, Matrix Requirements, or Jama).
- Technical Writing: Demonstrated experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
- Product Lifecycle: Proven track record of taking a medical device software product through a successful FDA clearance/approval process and subsequent launch.
Nice to have
- Standards Expertise: Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines.
- Tooling: Experience with modern software development workflows (e.g. Git, Jira) and quality system tools (e.g. Greenlight Guru, Arena, Matrix Requirements, or Jama).
Compensation
- Competitive compensation, including stock options.
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.
- We are seeking a Software Design Control Engineer to drive end-to-end documentation and process rigor across our Class III medical device software products, supporting both clinical trials and commercialization.
- You will bring medical device best practices across quality and engineering to ensure our software is safe, effective, compliant, and ready for market.
- Demonstrated experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
Company info
- 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.
- All applications will be treated confidentially. Applicants may be asked to sign an NDA after the initial stages of the interview process.
- Echo Neurotechnologies is an Equal Opportunity Employer (EOE).
- We celebrate diversity and are committed to creating an inclusive environment for all employees.
Apply directly at Echo Labs →Create a free account for alerts like thisView Echo Labs immigration profile
This listing is sourced directly from Echo Labs's careers page and normalized into a canonical job model.