Software Design Control Engineer

Jobtailor; San Francisco (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Jobtailor in San Francisco seeks a Regulatory Documentation Specialist for medical device software. You will author and maintain Design History Files, Traceability Matrices, and software validation reports to support compliance with IEC 62304, ISO 14971, and FDA guidelines.

The role requires 5+ years in medical device software, a related bachelor’s degree, and a proven FDA clearance/launch track record. You’ll work with cross‑functional teams to keep regulatory documentation current and

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.
• Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines.

Responsibilities

• Author, review, and maintain design control documentation (Software Requirements, Architecture & Design Documents, Traceability Matrices).
• Ensure development processes align with IEC 62304, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Produce software verification and validation protocols and reports with cross‑functional teams.
• Compile and organize documentation for regulatory submissions and post‑market surveillance.

Skills

Regulatory documentation

Regulatory compliance

Software validation

Version control

Education

Bachelor’s degree in CS / Biomedical Eng / Software Eng

Tools

Git

Jira

Greenlight Guru

Arena

Matrix Requirements

Jama

Job description

• 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

• 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).

Core Competencies

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.