Software Design Control Engineer

Restorative Neurotechnologies

Software Design Control Engineer ensuring compliance for Class III medical device software. Collaborating with engineers to maintain documentation and align with FDA regulations.

Posted 7/17/2026full-timeSan Francisco • California • 🇺🇸 United StatesMid-LevelSenior💰 $170,000 - $220,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in authoring and managing medical device software documentation, including compliance with IEC 62304, ISO 14971, and FDA regulations. Proven ability to navigate the FDA clearance process for software-driven medical devices.

Highest-signal resume keywords

Medical Device Software Documentation ManagementIEC 62304 ComplianceISO 14971 Risk ManagementFDA Clearance Process ExperienceModern Software Development Workflows

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software Requirements SpecificationsArchitecture & Design DocumentsTraceability MatricesSoftware FMEAsVerification and Validation ProtocolsDesign History FilesSoftware Technical Documentation

Tools & Technologies

GitJiraGreenlight GuruArenaMatrix RequirementsJama

Industry Keywords

Medical Device IndustryClass II Medical DevicesClass III Medical DevicesPost-Market SurveillanceCAPAs

About the role

Key responsibilities & impact

Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
Ensure software development processes align with IEC 62304 (Medical Device Software Lifecycle), 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 the engineering and test teams to ensure full traceability.
Compile and organize necessary software technical documentation for regulatory submissions.
Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.

Requirements

What you’ll need

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).

Benefits

Comp & perks

Competitive compensation, including stock options.
Comprehensive benefits package.
401(k) program with matching contributions.