Remote Senior Medical Device Software Engineer

Innolitics LLC; United States; On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Internet reimbursement

Equipment stipend

Job summary

Innolitics LLC is a remote-first company specializing in medical device software development and FDA regulatory consulting. We partner with medical device companies to bring new technologies to market, focusing on robust, traceable systems and regulatory-compliant documentation.

As a Senior Medical Device Software Engineer, you will contribute to software development and design assurance, while expanding your expertise in FDA submissions, cybersecurity, and lifecycle management in a fully remote

Qualifications

• 3+ years in a full-time software engineering role.
• Fluent coding in Python, C++, or TypeScript.
• Willing to travel 2–3 times per year.

Responsibilities

• Software development for medical device software, with emphasis on quality and regulatory alignment.
• Cybersecurity guidance and risk analysis support for FDA-related projects.
• Regulatory documentation, such as software requirements, risk assessments, and design specifications.
• Collaborate with regulatory professionals to ensure compliance and project timelines.

Skills

Python

C++

TypeScript

AI tools

Education

PhD/Masters/Bachelors in Computer Science or Biomedical Engineering

Job description

Innolitics LLC is a remote-first company specializing in medical device software development and FDA regulatory consulting. We partner with medical device companies to bring new technologies to market, focusing on robust, traceable systems and regulatory-compliant documentation.

As a Senior Medical Device Software Engineer, you will contribute to software development and design assurance, while expanding your expertise in FDA submissions, cybersecurity, and lifecycle management in a fully remote