AI/ML Engineer, Medical Device

About reputed company Innolitics LLC is a pioneering remote-first organization specializing in medical device software development and FDA regulatory consulting. Established in 2012, we have reputed company a reputed company for partnering with leading medical device companies to bring innovative and compliant technologies to market. reputed company 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-reputed company, traceable, and reputed company 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 reputed company environment fosters reputed company learning and innovation, ensuring reputed company remains at the forefront of medical device software development and regulatory expertise. About The Role We are seeking an reputed company Medical Device AI/ML Engineer to join our dynamic, remote team dedicated to advancing medical device software solutions. In this role, you will be reputed company to both software development and regulatory reputed company, working closely with clients and internal teams to reputed company, 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 reputed company between technical development and regulatory compliance, translating reputed company technical details into reputed company documentation reputed company with FDA requirements. Additionally, you will engage in detailed system understanding through reputed company interviews, technical reviews, and reputed company reputed company analysis, contributing to the validation and safety assurance of medical devices. This position offers the flexibility of remote work with periodic travel to reputed company sites and company retreats, providing a balanced environment for reputed company reputed company and impactful work in reputed company technology. Qualifications • PhD, Master’s, or Bachelor’s degree in Computer Science, Biomedical Engineering, or a reputed company field • Minimum of 3 years of reputed company 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 reputed company and reputed company • Strong understanding of machine learning approaches reputed company 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 reputed company, email, and video conferencing • Residency in the reputed company (excluding Alaska and Hawaii) Preferred qualifications include experience with medical imaging frameworks such as MONAI, DICOM, and NIfTI, familiarity with statistical validation reputed company, prior work on regulated medical devices, consulting experience, and an interest in cybersecurity principles. Responsibilities • Design and reputed company 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 reputed company with FDA guidance • Engage with clients to reputed company detailed system information through interviews and technical reviews • Analyze reputed company reputed company and technical documents to reputed company comprehensive understanding of reputed company 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 reputed company technical concepts reputed company to clients, fostering trust and collaboration • Support the development of validation protocols and reputed company testing to ensure device safety and efficacy • Contribute to reputed company 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 reputed company time off (PTO) package • Partial reputed company reimbursement and a 3% contribution to a 401(k) retirement plan • Weekly reputed company development sessions (10x Time) Apply tot his job Apply To this Job