Medical Device AI/ML Engineer

Medical Device AI/ML Engineer 🔗

Location: Remote (U.S. only)

Job Type: Full-time

About Us 🔗

Innolitics LLC 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 innovative technologies to market. Our team of engineers, consultants, and domain experts works at the intersection of software engineering and regulatory compliance to deliver high-quality solutions.

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.

As an engineer here, you will not only write production code and develop new machine learning models, but also develop expertise in medical device regulations, quality systems, verification and validation, and the realities of FDA-facing software.

If you’re excited by the intersection of technology, medicine, and regulation—and 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. At Innolitics, you will play a cross-functional role in both software development and regulatory projects. You will help develop new medical device software, including building out machine learning pipelines, training new models, and helping clients properly document and track their training, testing, and validation datasets. Additionally, you will help clients with existing software devices who need to remediate or entirely build out their technical design history file, leveraging deep technical expertise and client communication skills to produce a thorough, accurate representation of the software for regulatory submission— in collaboration with our team of regulatory experts.

This is a fully remote position with travel 2-3 times a year to clients and our annual company retreat.

Your Responsibilities Will Include 🔗

• Software and AI/ML Model 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. You will also participate in the design, training, and validation of new machine learning models.
• 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 the FDA understands. You'll ensure that all software documentation complies with FDA guidance.
• System Understanding: You’ll engage in detailed information gathering by interviewing client engineers, reviewing technical documents, and examining source code. You'll develop a comprehensive understanding of our client’s medical device systems and 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 the FDA. You’ll work closely with engineering teams to implement these processes efficiently.
• Project Collaboration: You’ll communicate effectively with both software engineers and regulatory professionals, acting as a bridge between technical and compliance teams. You’ll also be involved in planning project timelines, creating detailed meeting agendas, and keeping careful notes to ensure that all regulatory and development milestones are met.
• Client communication: You’ll interact directly with clients, communicating highly technical information in a way that is accessible and understandable. You will be a key part of building a trusting, productive, and collaborative relationship between us and our clients.

At Innolitics, you’ll be part of a team that is pushing the boundaries of what’s possible in medical device software. Your work will not only meet regulatory standards, but also make a real difference in patient care.

Who are we looking for? 🔗

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 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 a few 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

What We Offer 🔗

• Competitive base salary $120,000 - $150,000 depending on experience
• 10% performance-based bonus
• Fully remote work with flexible hours
• Comprehensive PTO package
• Partial healthcare reimbursement and automatic 3% contribution to a 401(k) retirement plan
• Weekly 10x Time
• Annual company retreat for team building and collaboration
• Mentorship from experienced regulatory and software professionals
• Strong career growth opportunities

What You'll Work On — Real Projects, Real Impact 🔗

Our engineers don't work on toy problems. Here's a sample of recent AI/ML projects our team has delivered:

Galileo CDS — Brain MRI Lesion Detection (FDA 510(k) Cleared)

After the FDA issued a rare Not Substantially Equivalent decision on the client's initial submission, our team executed a strategic pivot — rescoping the device, identifying a stronger predicate, and rebuilding the entire DHF, risk management file, and V&V protocols. The resubmission achieved FDA clearance. The client has since engaged us for a follow-on submission to expand the device's capabilities.

Cube Click (SmileDx) — Dental AI CADe (FDA 510(k) Cleared)

Built from the ground up. 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. Our team supported ML model development and regulatory documentation for volumetric segmentation of brain structures — work that directly impacts 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. A technically demanding project requiring robust performance across diverse MRI acquisition protocols.

Body Check — AI Cardiomegaly Detector (FDA 510(k) Cleared)

We Did It All: R&D, Clinical Study, and 510(k) Cleared in 12 Months

Innolitics did the entire project end-to-end — algorithm R&D using tools like MONAI, software engineering, clinical study design, FDA presubmission, 510(k) submission, and hold letter response. The AI cardiomegaly detector went from concept to FDA clearance in under 12 months.

RadUnity — DICOM Workflow Engine (FDA 510(k) Cleared)

We Built a Radiology Workflow Tool and Got It FDA Cleared in 14 Months

We developed a data-intensive DICOM image processing web application from the ground up — React frontend, Python backend, image processing server, and Orthanc DICOM router — then prepared and submitted the complete 510(k) package. Engineering and FDA clearance completed within 14 months.

Softek Illuminate — BRODERS Lung Nodule AI (In Progress)

End-to-end development of a lung nodule cancer prediction algorithm licensed from Mayo Clinic. Our engineers are performing the tech transfer, retraining and validating the ML model, building the clinical study infrastructure, and preparing the 510(k) submission targeting RSNA clearance.

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.

How to Apply 🔗

Please email jdgiese@innolitics.com your resume and a cover letter (3–4 short paragraphs) explaining why this role interests you and why you’re a good fit.

We are hiring as soon as we find the right person—so don’t hesitate to apply! If selected to move forward, you’ll hear from our team within 2–3 business days.