Description

About Us
Innolitics is a remote-first company specializing in medical device software development and FDA regulatory consulting. Since 2012, we've partnered with medical device companies to bring new technologies to market. Our team of engineers, consultants, and domain experts works at the intersection of software engineering and regulatory compliance.

Agentic AI tools like Claude Code and Codex are changing the day-to-day experience of software engineering. We see this as an opportunity, not a threat. We are a growing, collaborative team that is actively learning how to use these tools to produce robust, traceable, high-quality systems where correctness, safety, and documentation matter.

What you'll do
As a Medical Device Software Engineer at Innolitics, you'll play a cross-functional role in two types of projects:

1. Software development projects. You'll help develop new medical device software.
2. Design assurance / software validation projects. Once you've built up experience with FDA's medical device regulations, you'll help clients validate their software and create the software and cybersecurity documentation needed for regulatory submissions.

Your responsibilities will include

• Software development: You'll participate in the design and development of new medical device software. You'll write clean, efficient code and ensure it meets both functional requirements and regulatory standards. Your work will involve constructing software systems, drafting software unit and system tests, and implementing robust testing methodologies.
• Cybersecurity: With support from cybersecurity experts on our team, you'll guide clients through threat modeling and security risk analysis, ensuring their systems are secure and comply with FDA requirements.
• Regulatory compliance: You'll collaborate with regulatory professionals to write technical documents, such as software requirements specifications, software risk assessments, and software design specifications, in language that FDA understands. You'll ensure that all software documentation complies with FDA guidance.
• System understanding: You'll gather information by interviewing client engineers, reviewing technical documents, and examining source code. You'll develop a comprehensive understanding of our clients' medical device systems, help validate that they're safe, and document their functioning.
• Configuration and lifecycle management: You'll advise clients on best practices for configuration management, AI/ML data controls, and other software development processes required by FDA, and work with their engineering teams to implement these processes efficiently.
• Project collaboration: You'll communicate with both software engineers and regulatory professionals, acting as a bridge between technical and compliance teams. You'll plan project timelines, create detailed meeting agendas, and keep careful notes so that regulatory and development milestones are met.

Requirements

Someone who

• Believes in our mission
• Shares our values
• Has a PhD, Masters, or Bachelors in Computer Science, Biomedical Engineering, or a related field
• Has 3+ years of experience in a full-time software engineering role
• Is able to code fluently in Python, C++, or TypeScript
• Is fluent in the use of AI tools as a productivity multiplier
• Is capable of learning new technologies quickly and independently
• Wants to learn about medical devices and the FDA regulations that apply to them
• Is willing to travel 2–3 times a year (client visits and our annual retreat)
• Can communicate fluently in English via Slack, email, and video calls
• Lives in the United States (excluding Alaska and Hawaii)

Ideal candidates will also

• Be familiar with web technologies and cloud infrastructure
• Have experience or interest in cybersecurity
• Have experience with mobile app development