AI/ML Engineer, Medical Device

About The Company Innolitics LLC is a pioneering remote-first organization specializing in medical device software development and FDA regulatory consulting. Established in 2012, we have built a reputation for partnering with leading medical device companies to bring innovative and compliant technologies to market.

Our team comprises highly skilled engineers, regulatory consultants, and domain experts who operate at the intersection of software engineering and regulatory compliance. We are committed to delivering high-quality, traceable, and safe medical device solutions that meet stringent FDA standards. As the landscape of medical technology evolves with AI and machine learning, Innolitics embraces these advancements as opportunities to enhance patient care and device performance.

Our collaborative environment fosters continuous learning and innovation, ensuring our team remains at the forefront of medical device software development and regulatory expertise.

About The Role

We are seeking an experienced Medical Device AI/ML Engineer to join our dynamic, remote team dedicated to advancing medical device software solutions. In this role, you will be integral to both software development and regulatory projects, working closely with clients and internal teams to develop, document, and validate AI/ML models and systems for FDA-regulated devices.

Your responsibilities will include designing and implementing machine learning pipelines, training and testing models, and ensuring comprehensive documentation for regulatory submissions. You will serve as a bridge between technical development and regulatory compliance, translating complex technical details into clear documentation aligned with FDA requirements. Additionally, you will engage in detailed system understanding through client interviews, technical reviews, and source code analysis, contributing to the validation and safety assurance of medical devices.

This position offers the flexibility of remote work with periodic travel to client sites and company retreats, providing a balanced environment for professional growth and impactful work in healthcare technology.

Qualifications

• PhD, Master’s, or Bachelor’s degree in Computer Science, Biomedical Engineering, or a related field

• Minimum of 3 years of professional experience in software engineering

• At least 3 years of experience with image processing and deep neural networks

• Proficiency in Python and PyTorch

• Experience with AI tools such as Claude Code and Codex

• Strong understanding of machine learning approaches beyond neural networks

• Ability to quickly learn new technologies and adapt to evolving project requirements

• Interest in medical devices and FDA regulatory processes

• Willingness to travel 2-3 times per year

• Excellent communication skills in English, proficient in Slack, email, and video conferencing

• Residency in the United States (excluding Alaska and Hawaii)

Preferred qualifications include experience with medical imaging frameworks such as MONAI, DICOM, and NIfTI, familiarity with statistical validation methods, prior work on regulated medical devices, consulting experience, and an interest in cybersecurity principles.

Responsibilities

• Design and develop new medical device software, ensuring compliance with regulatory standards

• Construct, train, and validate machine learning models for medical applications

• Write and maintain technical documentation including software requirements, risk assessments, and design specifications aligned with FDA guidance

• Engage with clients to gather detailed system information through interviews and technical reviews

• Analyze source code and technical documents to develop comprehensive understanding of client devices

• Advise clients on configuration management, data controls, and lifecycle processes necessary for regulatory compliance

• Collaborate effectively with software engineers and regulatory teams to meet project milestones

• Communicate complex technical concepts clearly to clients, fostering trust and collaboration

• Support the development of validation protocols and perform testing to ensure device safety and efficacy

• Contribute to continuous improvement of development processes and regulatory strategies

Benefits

• Competitive annual salary ranging from $120,000 to $150,000, commensurate with experience

• Performance-based bonus of 10%

• Fully remote work environment with flexible working hours

• Comprehensive paid time off (PTO) package

• Partial healthcare reimbursement and a 3% contribution to a 401(k) retirement plan

• Weekly professional development sessions (10x Time)