Software Design Control Engineer

Echo Neurotechnologies; United States; On-site; USD 170,000 - 220,000; Full time

Benefits offered by this job

Stock options

Comprehensive benefits

401(k) with matching

Job summary

Echo Neurotechnologies seeks a Software Design Control Engineer to drive end-to-end design control documentation for Class II/III medical device software, ensuring safety, effectiveness, and regulatory readiness for trials and commercialization.

You will collaborate with software, quality, and regulatory teams to maintain traceability, conduct risk management, and prepare regulatory submissions while supporting post-market surveillance and updates.

Qualifications

• Experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
• Proven track record taking a medical device software product through FDA clearance/approval and launch.
• Knowledge of IEC 62304, ISO 14971, and FDA Software Validation Guidelines.
• Experience with software validation and verification activities in regulated environments.

Responsibilities

• Author, review, and maintain design control documentation (SRS, Architecture & Design Documents, Traceability Matrices).
• Ensure software development processes align with IEC 62304, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Maintain software risk management files per ISO 14971 and coordinate V&V protocols with engineering teams.
• Prepare software documentation for regulatory submissions and post-market updates.

Skills

Regulatory compliance

Technical writing

Quality assurance

Risk management

Education

Bachelor's degree in Computer Science / Biomedical Engineering / Software Engineering or related field

Tools

Git

Jira

Greenlight Guru

Arena

Matrix Requirements

Jama

Job description

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: 5 years of experience in the medical device industry, specifically working with software-driven or connected medical devices (Class II or Class III).
• Technical Background: A Bachelor's degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience.
• 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

• 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).
• 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.