Echo Neurotechnologies

Implantable brain-computer interface enabling communication

Software Design Control Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeSan Francisco, CA, USAIn-person

About the Job

Requirements

10+ years of experience in the medical device industry, specifically with software-driven or connected medical devices (Class II or Class III).
Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines, with hands-on design-control experience applying them through at least one full software lifecycle from requirements to FDA submission and clearance.
A bachelor's degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience, with strong technical skills to read code and architecture, align technical scope with engineers, and ensure consistency across documents.
Demonstrated experience writing, reviewing, and managing formal medical device software documentation, including Design History Files and Traceability Matrices.
A proven track record of taking a medical device software product through a successful FDA clearance or approval process and subsequent launch.

Responsibilities

Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture and 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 protocols and reports in coordination with the engineering and test teams to ensure full traceability.
Compile and organize software technical documentation for regulatory submissions.
Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.

Desired Qualifications

Exposure to cloud, cybersecurity, or machine learning/artificial intelligence software documentation in a regulated context.
Experience with modern software development workflows such as Git and Jira, and quality system tools such as Greenlight Guru, Arena, Matrix Requirements, or Jama.
Experience maintaining medical device software post-launch, including managing software changes and compliance updates.

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.

Job Description

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. This role sits at the intersection of software engineering, quality systems, and regulatory compliance. You will bring medical device best practices across quality and engineering to ensure our software is safe, effective, compliant, and ready for market.

Role Responsibilities

Embedded Design Controls: Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
Lifecycle Compliance: Ensure software development processes align with IEC 62304 (Medical Device Software Lifecycle), ISO 13485, and FDA 21 CFR Part 820 regulations.
Risk Management: Author and maintain software risk management files, including Software FMEAs per ISO 14971.
V&V Partnership: Produce software verification and validation (V&V) protocols and reports in coordination with the engineering and test teams to ensure full traceability.
Regulatory Submission Prep: Compile and organize necessary software technical documentation for regulatory submissions.
Post-Market Support: Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.

Qualifications

Required Qualifications

Experience: 10+ years of experience in the medical device industry, specifically working with software-driven or connected medical devices (Class II or Class III).
Standards Expertise: Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines, with hands-on design-control experience applying these through at least one full software lifecycle from requirements to FDA submission and clearance.
Technical Background: A Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience, resulting in strong technical skills to read code and architecture, align technical scope with engineers, and ensure consistency across documents.
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.

Preferred Qualifications

Broad Technical Skills: Exposure to cloud, cybersecurity, or ML/AI software documentations in a regulated context
Tooling: Experience with modern software development workflows (e.g. Git, Jira) and quality system tools (e.g. Greenlight Guru, Arena, Matrix Requirements, or Jama).
Post-Market Management: Experience maintaining medical device software post-launch, including managing software changes and compliance updates.

Salary

$170,000—$220,000 USD

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.

Salary 170000 - 220000 USD

About the Company

Echo Neurotechnologies

Implantable brain-computer interface enabling communication

Echo Neurotechnologies creates brain-computer interfaces (BCIs) aimed at helping people with severe neurological disabilities regain abilities such as conversational communication. Its main product is an implantable BCI system that surgically places electrodes on the brain to record neural signals, which are then decoded by software (potentially using AI) to control external devices or generate speech through a digital avatar. This makes it possible for users to interact with computers or robotic limbs by thinking. The company differentiates itself through leadership from Dr. Edward Chang and a focus on clinically translating BCIs for restoration of communication and movement, backed by venture funding from Andreessen Horowitz and a plan to move toward commercialization in a field with players like Neuralink and Synchron. The goal is to bring therapeutic neural implants to patients, enabling restored communication and mobility for those with severe paralysis.

Company size: Not listed
Company stage: Late Stage VC
Total funding: $50M
Headquarters: San Francisco, CA
Founded: 2023

Recently Posted Jobs

Explore more opportunities at Echo Neurotechnologies

See more jobs