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Software Design Control Engineer at Echo Bio - ApplyBlast

Software Design Control Engineer

Echo Bio

3 months ago

San Francisco, United States

Onsite

Full Time

Senior

0 applicants

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About this role

A Software Design Control Engineer at Echo Neurotechnologies drives end-to-end documentation and process rigor for Class III medical device software products. The role bridges software engineering, quality systems, and regulatory compliance to ensure products are safe, effective, and ready for market. Responsibilities include authoring design control documentation, managing risk files, and preparing technical data for FDA submissions.

Responsibilities

Author and maintain comprehensive design control documentation and traceability matrices
Ensure software development processes align with IEC 62304 and ISO 13485 regulations
Produce software verification and validation protocols and reports
Compile technical documentation for regulatory submissions and post-market surveillance
Manage software risk management files including Software FMEAs per ISO 14971

Skills

Qualifications

Bachelor's degree in Computer Science, Biomedical Engineering, or Software Engineering5+ years of experience in the medical device industryExperience with IEC 62304, ISO 14971, and FDA Software Validation GuidelinesProven track record of FDA clearance/approval processExperience with quality system tools like Greenlight Guru or Jama

About Echo Bio

echo.bio

Echo Bio is a biotechnology company focused on developing advanced tools and platforms for biological research and healthcare applications. The company works at the intersection of life sciences, engineering, and data to support better analysis, diagnostics, or laboratory workflows. Echo Bio operates in the biotechnology industry, building technology that helps researchers and healthcare organizations work more effectively.