Senior Product Manager – Medical Imaging & AI Systems

Senior Product Manager – Medical Imaging & AI SystemsLocation: Remote / North Dakota / California (Flexible) Company: SafetySpect Inc.About SafetySpect: SafetySpect Inc. is a pioneering medical and environmental imaging company leveraging advanced optical sensing and artificial intelligence to revolutionize contamination detection, wound management, and hygiene verification. Backed by a prestigious award from a major federal health innovation agency, SafetySpect is scaling up operations and launching a new generation of intelligent imaging systems in healthcare and food safety markets.Position Overview: We are seeking a highly experienced Senior Product Manager with a strong track record in medical devices, preferably with a focus on optical systems and AI-powered platforms. This role will be instrumental in driving product strategy, development, and market deployment of our imaging and spectroscopy platforms. The ideal candidate will have deep experience managing complex product lifecycles from concept through regulatory approval and commercialization.Responsibilities:Lead the development roadmap for edgecomputing imaging platforms from concept through launch.Collaborate with cross-functional teams including engineering, clinical, AI/ML, regulatory, and marketing.Translate customer needs and regulatory requirements into clear product requirements and specifications.Drive competitive analysis, user research, and voice-of-customer (VoC) initiatives.Manage design control documentation in compliance with FDA and ISO 13485 QMS standards.Support government-funded milestones, ensuring deliverables are aligned with project goals.Coordinate with manufacturing and QA to ensure DFM (design for manufacturability) and risk mitigation.Champion product vision and value proposition with internal stakeholders and external partners.Identify market opportunities and support pricing, launch, and go-to-market strategies.Qualifications:7+ years of experience in product management, ideally in medical devices or AI-enabled imaging systems.Proven success in managing regulated products under FDA QSR (21 CFR Part 820) and/or ISO 13485.Experience with optical sensing, fluorescence imaging, or spectral analysis is strongly preferred.Strong understanding of AI/ML integration in hardware/software platforms.Exceptional leadership, communication, and cross-functional coordination skills.Ability to work in a fast-paced, mission-driven startup environment.Bachelor’s or Master’s degree in engineering, life sciences, or related field; MBA or PMP a plus.