Location: Remote (U.S. only, excluding Alaska and Hawaii)
Job Type: Full-time
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.
We are hiring a principal engineer who has already shipped regulated medical device software. You will lead client projects from concept to clearance. On a typical week, you will write code for a new SaMD product, review a client's software development plan against IEC 62304, draft a software description for a 510(k), and explain to a client's CEO why a change requires a new submission. You will be the person in the room who understands both the code and the regulation.
Someone who
Experience with ISO 14971, IEC 62366, FDA cybersecurity guidance, AI/ML PCCPs, or cloud infrastructure with Terraform is a plus.
We only take on projects we believe improve the world. Recent projects include software for radiation oncology clinics, a device that detects ear infections, open-source software used by neurosurgeons and researchers, an AI cardiomegaly detector that went from concept to FDA clearance in under 12 months, and software for tracking metastatic cancer. See our portfolio for more.
The salary for the position is $200,000–$250,000/year, depending on education and experience. We also have a 10%–12% annual bonus tied to hitting billing utilization targets.
We operate exclusively in the healthcare sector and do not take on debt, which shields us from boom and bust economic cycles. We have never had to lay off employees because of a recession.
We're tight-knit, profitable, and growing quickly. If you work with us you can participate in our growth and help define the direction we move in. You can wear many hats and contribute to the company beyond software development.
Work with a team of talented, mission-driven engineers who will help you become a better engineer. We're a close-knit group, despite being fully remote.
We invest in the personal and professional development of all our team members. We dedicate two hours on Wednesday afternoons to ongoing learning. Here is a list of our previous learning topics. You'll also have opportunities to change projects from time to time.
We've been remote-only since 2012, so we know how to run a remote company effectively. You can live anywhere in the United States except Alaska and Hawaii.
We provide a 401(k) with Traditional and Roth options. Innolitics contributes 3% of your salary annually once you've worked with us for six months, vesting immediately. The plan includes very low-cost index funds and we cover all plan costs.
We provide company health insurance (details in our handbook). We reimburse internet costs up to $1,200/year and provide a $750/year equipment stipend.
Please fill out this form to apply. The cover letter you upload should be three or four short paragraphs explaining why this position in particular interests you and why you are a great fit. Also include which regulated products you worked on, which submissions you contributed to, and what you did on them.
We'll read your email and review your resume. If we don't think you're a good fit, we'll let you know. We probably won't respond if you don't live in the US or haven't explained why you want to work at Innolitics in particular.
If it looks like you're a good fit, we'll get in touch. The interview process involves a couple of interviews and a take-home activity writing short documents for an imaginary medical device. We'll also require two reference checks.