Senior Medical Device Software Engineer - Regulatory & Security

Sacbar; Austin (TX); On-site; USD 120,000 - 160,000; Full time

Job summary

Innolitics seeks a Medical Device Software Engineer to drive both software development and regulatory design assurance for medical device projects. The role spans writing code, performing cybersecurity work, and creating FDA-aligned documentation.

You will collaborate with regulatory professionals, gather system information, and ensure traceability and compliance while applying modern AI-assisted tooling and secure software practices.

Qualifications

• PhD, Masters or Bachelors in Computer Science, Biomedical Engineering, or a related field.
• 3+ years of experience in a full-time software engineering role.
• Fluent coding in Python, C++, or TypeScript.
• Fluent in using AI tools as productivity multipliers.
• Willing to travel 2–3 times per year.
• Resides in the United States (excluding Alaska and Hawaii).

Responsibilities

• Software development: design and develop new medical device software with robust testing.
• Cybersecurity: guide threat modeling and security risk analysis to meet FDA requirements.
• Regulatory compliance: write software requirements, risk assessments, and design specifications for FDA submissions.
• System understanding: interview client engineers, review documents, and examine source code.
• Lifecycle management: advise on configuration management and data controls per FDA recommendations.
• Project collaboration: coordinate with software and regulatory teams to meet milestones.

Skills

Python

C++

TypeScript

AI productivity tools

Communication in English

Education

PhD/Masters/Bachelors in CS or Biomedical Engineering

Job description

Innolitics seeks a Medical Device Software Engineer to drive both software development and regulatory design assurance for medical device projects. The role spans writing code, performing cybersecurity work, and creating FDA-aligned documentation.

You will collaborate with regulatory professionals, gather system information, and ensure traceability and compliance while applying modern AI-assisted tooling and secure software practices.