--- title: Senior Medical Device AI/ML Engineer --- ## Medical Device AI/ML 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. If you\'re excited by the intersection of technology, medicine, and regulation, and you enjoy organizing and clarifying complex information, you\'ll feel at home here. ### About the Role We\'re hiring an experienced AI/ML engineer to join our tight-knit team of medical device developers. You will play a cross-functional role in both software development and regulatory projects. [You\'ll help develop new medical device software](https://innolitics.com/services/end-to-end-samd/), including building machine learning pipelines, training new models, and helping clients properly document and track their training, testing, and validation datasets. You\'ll also [help clients with existing software devices](https://innolitics.com/services/guided-510k/) who need to remediate or build out their design history file, working with our regulatory experts to produce a thorough, accurate representation of the software for regulatory submission. This is a fully remote position with travel 2--3 times a year (client visits and our annual retreat). ### Your responsibilities will include - **AI/ML model development**: You\'ll participate in the design, training, and validation of new machine learning models, including curating and tracking the datasets behind them and analyzing model performance with appropriate statistical methods. - **Software development**: You\'ll write clean, efficient code that 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. - **Regulatory compliance and documentation**: 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. - **Client communication**: You\'ll interact directly with clients, communicating highly technical information in an accessible way, and help build trusting, productive, collaborative relationships. 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 professional software engineering role - Has 3+ years of experience with image processing and deep neural networks, plus familiarity with other machine learning approaches - Is fluent in Python and PyTorch - 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 - Can communicate fluently in English via Slack, email, and video calls - Lives in the United States (excluding Alaska and Hawaii) Ideal candidates will also - Have experience with medical imaging frameworks and data formats, including MONAI, DICOM, and NIfTI - Have experience with statistical methods for analyzing, validating, and presenting results - Have a track record of successful AI/ML projects - Have experience working with regulated medical devices - Have experience working as a consultant in a client-facing role - Have experience or interest in learning about 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. A sample of recent AI/ML projects our team has delivered: **Galileo CDS, brain MRI lesion detection (FDA 510(k) cleared).** After FDA issued a rare Not Substantially Equivalent decision on the client\'s initial submission, our team rescoped the device, identified a stronger predicate, and rebuilt the DHF, risk management file, and V&V protocols. The resubmission achieved FDA clearance, and the client has since engaged us for a follow-on submission. **Cube Click (SmileDx), dental AI CADe (FDA 510(k) cleared).** Our engineers developed the full ML pipeline and software system for a computer-aided detection device in dental imaging, then took it through FDA clearance end to end. **GyriCalc, neuroanatomy segmentation (FDA 510(k) cleared).** An AI-powered neuroanatomy measurement tool for brain MRI. We supported ML model development and regulatory documentation for volumetric segmentation of brain structures, work that directly supports diagnosis and monitoring of neurodegenerative conditions. **Neosoma, brain metastases AI.** AI/ML strategy, clinical study design, and Pre-Submission preparation for an automated brain metastases detection and segmentation tool, requiring robust performance across diverse MRI acquisition protocols. **Body Check, AI cardiomegaly detector (FDA 510(k) cleared).** Innolitics did the entire project end to end: algorithm R&D using tools like MONAI, software engineering, clinical study design, FDA Pre-Submission, 510(k) submission, and hold letter response. Concept to FDA clearance in under 12 months. **Softek Illuminate, BRODERS lung nodule AI (in progress).** End-to-end development of a lung nodule cancer prediction algorithm licensed from Mayo Clinic: tech transfer, retraining and validating the ML model, building the clinical study infrastructure, and preparing the 510(k) submission. Across these and 60+ other projects since 2013, our engineers work directly with FDA-regulated AI/ML systems spanning medical imaging, risk prediction, and clinical decision support, across 18 unique FDA product codes and approaching 100 total clearances. #### 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. #### Talented and fun teammates We\'re tight-knit, profitable, and growing quickly. Work with a team of talented, mission-driven engineers who will help you become a better engineer. You can wear many hats and contribute to the company beyond engineering. #### 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/). #### 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. We hold an [annual company retreat](https://innolitics.com/about/handbook/#retreats). #### 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. In the cover letter section, write 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 review your application. 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 software documentation for an imaginary medical device. We\'ll also require two reference checks.