Innolitics is a remote-only professional services firm. We help medical device companies, from startups to large corporations, develop software and AI for medical devices, validate safety and security, and navigate FDA regulations. We’d love to have you join our team!
The people you would work with. Meet the team
Lead client projects from design control through submission. Write SaMD code, review software plans against IEC 62304, and draft the software sections of 510(k) submissions.
Lead implementations of Medtech OS, our Notion-based quality management system, and provide ongoing quality services to medical device companies building software and AI devices.
Lead client projects from concept to clearance. Write code for new SaMD products, review software plans against IEC 62304, draft 510(k) software sections, and explain regulatory trade-offs to client executives.
Lead demand generation and content marketing, from LinkedIn posts, the newsletter and webinars to conferences and the website, measured by qualified leads for the sales team.
This map shows a typical project from concept to FDA clearance, in eight stages. Every role sits in one lane and works with the other four. Pick a role to see which lanes it owns, which it shares, and which it needs to follow. Select any task to see who you work with.
Scroll sideways to see all eight stages.
Risk workshops. Containerize the algorithm.
For this role:
Write requirements alongside cybersecurity's threat model and clinical's hazard input, so every risk control lands as a testable requirement. Quality checks the trace before the Phase 1 review.
Open the task page: decisions, examples, articlesNobody is expected to know everything. You are expected to know what to ask, and who can answer it.
Every project needs engineering, cybersecurity, regulatory, clinical and quality work. Nobody here covers all five. Each role owns one discipline and learns enough of the other four to know what to ask and whom to ask. A question you raise in your discipline gets answered by a teammate in another.
Each opening below lists the disciplines the role knows, knows some of, and is aware of. They map to the centers and rings in the figure below.
Nobody here knows all five disciplines. Everyone knows whom to ask.
Each circle is one discipline. The filled center is what that expert knows and can answer. The dashed ring is what they are aware of: the questions they know to ask. Outside every ring are questions nobody on the team knows to ask.
Five experts who each stay inside their own discipline.
Each expert answers the questions in their own field. A question that belongs to another field is never asked.
The gap shows up late, in verification or in an FDA deficiency letter, and fixing it means rework across code and documents.
The same five experts, each aware of what the other four do.
Each expert keeps their own discipline and learns enough of the other four to know what to ask and whom to ask.
A question raised in one discipline on day one is answered by a teammate in another, before it reaches code or the submission.
You are expected to know your own discipline well, and to know what to ask of the other four.
At Innolitics, we are at the forefront of a rapidly evolving industry that increasingly relies on software and AI. As part of our team, you’ll work on projects that improve patient care and safety. From developing AI-driven diagnostics to ensuring cybersecurity, you’ll push the boundaries of what's possible.
In this dynamic field, both regulations and technology are constantly changing. Success requires continuous learning and growth. We foster a collaborative and flexible environment that encourages this. For example, we dedicate two hours each week to "10x Time," where we explore technical and regulatory topics.
We only work on fulfilling projects—ones that we believe improve the world. For example, our current projects include software for radiation oncology clinics, a startup building an medical device to detect ear infections, open-source software used by neurosurgeons and researchers, software for tracking metastatic cancer, and several others. See our portfolio for more examples.
You can see past projects in our portfolio.
We pay competitive salaries, including profit sharing bonuses.
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. There will also be opportunities to grow your career. You can also 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 also a lot of fun and have a close-knit group, despite being fully-remote.
We invest in the personal and professional development of all our team members. We dedicate two and a half 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 and be involved with many more.
We’ve been remote-only since 2012. You can live wherever you want within the United States except for Alaska and Hawaii.
We love what we do, but we also have lives outside of work. We have flexible work hours. You are free to work at your own schedule as long as you are not blocked or do not block others. Most individual contributors have an hour worth of meetings a week.
We provide two weeks of paid time off your first year, three weeks your second and third years, and four weeks for each year after that.
We provide a 401(k), with Traditional and Roth options. Innolitics makes an annual contribution, equal to 3% of your salary, to your 401(k) once you’ve worked with us for six months. This contribution vests immediately. The 401(k) plan includes very low-cost index mutual funds, and we cover all the plan costs.
We provide company health insurance (read more about this in our handbook). We reimburse internet costs up to $1200/year and provide a $750/year equipment stipend.
Pick the role that fits the work you want to do. Each posting lists the tasks you would own at every stage of a project, and the disciplines you would work with.
We don't always remember to, but we try to announce all new positions on Twitter @innoliticsdev.