--- title: Senior Medical Device Software Engineer --- **Location:** Remote (U.S. only, excluding Alaska and Hawaii) **Job Type:** Full-time ### 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](https://innolitics.com/services/end-to-end-samd/). 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. The two types overlap, since we validate the software we develop. We currently have much more demand for software development projects, so expect that to be your main focus for at least your first year. ### 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](https://innolitics.com/articles/#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. ### Who are we looking for? Someone who - Believes in [our mission](http://innolitics.com/about/mission-and-values/#mission) - Shares [our values](http://innolitics.com/about/mission-and-values/#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 with mobile app development - Have experience or interest in cybersecurity ### Why would you want to work for us? #### Learn skills a software job won\'t teach you Alongside writing production code, you\'ll learn how medical devices get to market: requirements and risk management, verification and validation, quality systems, and FDA submissions. You\'ll practice these on real client projects, with mentorship from people who have taken dozens of devices through FDA clearance. Most software engineers never get this exposure; here it\'s the core of the job. #### Meaningful work 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](https://innolitics.com/portfolio/) for more. #### Compensation The salary for the position is \$120,000--\$150,000/year, depending on education and experience. We also have a 10%--12% annual bonus tied to hitting billing utilization targets. #### Financially stable 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. #### Tight-knit and growing 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. #### Talented and fun teammates 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. #### Stay relevant We invest in the personal and professional development of all our team members. We dedicate [two hours on Wednesday afternoons](https://innolitics.com/about/handbook/#10x-time) to ongoing learning. Here is a [list of our previous learning topics](https://innolitics.com/10x/discussions/). You\'ll also have opportunities to change projects from time to time. #### Remote only We\'ve been [remote-only](https://innolitics.com/about/handbook/#we-are-a-fully-remote-team) since 2012, so we know how to run a remote company effectively. You can live anywhere in the United States except Alaska and Hawaii. #### Benefits 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](https://innolitics.com/about/handbook/#health-insurance)). We reimburse internet costs up to \$1,200/year and provide a \$750/year equipment stipend. ### How to apply Please fill out [this form](https://innolitics.notion.site/348bd5b7a75480b7a354e6993f06a68d) 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. ### What happens after you apply 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.