Junior Product Manager at ChromoLogic LLC in Monrovia, CA

Summary: ChromoLogic LLC is a world-class innovation center specializing in advanced scientific research and development in the medical, aerospace, and security markets. They are seeking a Junior Product Manager to help bring innovative medical technologies from concept to market, collaborating closely with engineers, scientists, and regulatory experts to influence patient care outcomes. Responsibilities: - Partner closely with R&D, regulatory, and quality teams to support product development and design control activities under FDA 21 CFR Part 820 and IEC 62304 for medical device software - Translate user needs into clear product requirements and success metrics for emerging hardware–software systems - Coordinate verification, validation, and usability testing—ensuring every requirement has proper traceability - Maintain and organize DHFs, risk analyses, and other quality system documentation with precision - Contribute to regulatory submissions (e.g., 510(k), De Novo) and participate in FDA pre‑submission discussions - Collaborate with software teams to prioritize bugs, features, and updates that align with clinical workflows and user insights - Support agile processes—sprint planning, backlog management, and documentation—using tools like Jira & Confluence - Assist in post‑market monitoring, performance tracking, data analysis, and CAPA activities - Analyze competitive products, market trends, and unmet needs to guide product strategy and differentiation opportunities Required Qualifications: - Bachelor's degree in Biology, Bioengineering, Biomedical Engineering, or related technical field - 1–3 years of experience in medical device product management, regulatory support, or R&D coordination (internships count) - Working knowledge of FDA design controls, software validation, and risk management principles - Ability to excel in a dynamic, cross‑functional, startup environment where iteration is fast and teamwork is essential - Strong communication and documentation skills—comfortable shifting between technical deep dives and high‑level stakeholder discussions Preferred Qualifications: - Exposure to SaMD (Software as a Medical Device) or connected health platforms - Experience with early-phase product testing, clinical collaboration, or pilot deployments - Passion for scaling medical innovations that merge biology, engineering, and digital technology Required Skills: FDA 21 CFR Part 820, IEC 62304, medical device product management Important Skills: Jira, Confluence, risk management principles Nice-to-Have Skills: data analysis Benefits: Competitive salary and benefits package, A mission-driven culture where discovery and innovation are at the heart of everything, Close collaboration with scientists and leaders shaping breakthrough research, A chance to build something meaningful—your systems, your ideas, your leadership, Flexible environment, high ownership, and the ability to make an immediate impact