Product Owner

About FibriCheck FibriCheck is a CE class IIa and FDA-cleared Software as a Medical Device (SaMD) for the detection and monitoring of cardiac arrhythmias, including atrial fibrillation, via fingertip PPG. We are a 22-person medtech scale-up (headquartered in Hasselt, Belgium) with an established and proven life‑saving product and a clear roadmap for growth. Our product spans a patient‑facing mobile app, a web portal for healthcare providers, and a certified algorithm. We operate in both the EU and the US, working closely with healthcare providers, insurers, and research partners. The Role We are looking for a Product Owner with strong functional analysis skills and a sharp UX sensibility. The Product Manager (PM) sets priorities, owns the roadmap and business requirements. You translate those into designs, detailed functional specifications, and backlog items that the engineering team can build from without ambiguity. You will work closely with the Product Manager (who you will report to), the Head of Engineering and, when relevant, directly with (prospective) customers and users to validate UX and gather structured product feedback. You act as the primary bridge between the PM’s product vision and the engineering team’s day‑to‑day work, ensuring specifications are unambiguous and technically actionable. What You’ll Do Product Specification Translate business requirements into clear, unambiguous functional specifications ready for engineering (using Jira and MatrixReq). Maintain the product backlog: write and refine user stories and acceptance criteria in close collaboration with the PM and Head of Engineering. Review test cases written by the test engineer to ensure they correctly reflect the intended specifications and treat gaps as a signal to sharpen the spec. Join prospective customer calls at the concrete collaboration stage, articulating product capabilities, positioning and roadmap directions with confidence. Design & UX Create wireframes, interaction flows, and prototypes that translate product requirements into concrete design proposals. Validate UX assumptions with end users — patients, physicians, and clinical staff — and feed learnings back into the spec. Conduct customer design review sessions at the concrete collaboration stage and facilitate structured input gathering. Regulatory & Process Own the traceability between user needs, software requirements, and design outputs — ensuring software lifecycle documentation per IEC 62304 and ISO 13485 is complete, current, and audit‑ready at all times. Plan and drive usability validation activities (formative and summative) as structured milestones in the development cycle, not afterthoughts bolted on before release. Actively participate in sprint ceremonies and work with the Head of Engineering to balance scope, quality, and delivery. Continuously look to improve development and release procedures, making them leaner, clearer and faster while keeping them fully compliant in collaboration with our Head of Engineering; if something is unclear or slowing the team down, fix it. Close the post‑market surveillance loop by translating PMS signals, PMCF findings, and complaint trends into concrete backlog items, making regulatory obligations visible and actionable in the product roadmap. Who You Are Experience & Skills Product ownership in regulated software. Experience as a Product Owner or Functional Analyst in a SaMD, medical device, or similarly regulated environment and familiarity with ISO 13485 and IEC 62304 or a genuine drive to get up to speed fast. UX and design skills. You can move from a business requirement to a wireframe or prototype independently. Experience with tools like Figma, Claude design or equivalent is a plus. You understand what good interaction design looks like for clinical and patient‑facing products. Structure and documentation‑minded, but pragmatic. You know when a lightweight spec is enough and when you need to go deeper. You write clearly and structure your work so others can build on it. Strong communicator. Comfortable in a sprint planning session, a design review with a clinician, and a call with a prospective B2B partner. Languages. Full professional proficiency in English is required (written and spoken). AI‑native workflow. You actively use LLMs and AI‑assisted tools to work smarter and faster. This is a requirement for our way of working, not a nice‑to‑have. We work with Claude as our preferred tool. Working Style Autonomous and proactive. You do not need constant direction. You identify what needs to happen, you make a plan, and you execute. Ownership‑driven. You treat the product and timelines as your own responsibility, not a task list. Quality, completeness, and regulatory correctness are yours to uphold. Collaborative without being dependent. You work well in a small, horizontally structured team. You know when to escalate versus when to decide. You are not afraid to push back when things are unclear or unrealistic. EU‑based, office‑present. We are based in Hasselt (Corda Campus). Hybrid setup, but regular in‑office presence is expected (min 1 day/week). Full‑time commitment. This is a full‑time role. We are looking for someone who is fully embedded in the team, not a fractional or part‑time arrangement. What We Offer A central role in a small, high‑impact product team developing certified medical software used by over a million patients and individuals. Direct collaboration with the PM, Head of Engineering, and clinical and regulatory experts. Competitive compensation package including mobility budget, health insurance and other standard benefits. Flexible, hybrid work arrangements (Office: Hasselt, Corda Campus). #J-18808-Ljbffr