Company ProfileAs an internationally expanding Digital Health start-up, we are a leader in the field of AI-powered analysis ofimaging data for orthopedics and radiology. Our vision is to leverage AI solutions to enable early diagnosisand to measurably improve surgical success and patient outcomes. You are energetic, curious but alsopersistent? Then you are exactly right to bring in your skills to push our further expansion We offer anattractive workplace in an agile, fast-growing company and an open communication and corporate culture.The TasksWe are looking for a Product Manager with strong PO execution skills to bridge the gap between clinicalneeds and technical excellence. You will own the entire lifecycle of our Software as a Medical Device (SaMD),ensuring our AI tools are not only compliant but indispensable to clinicians. Your mandate is simple butdemanding: We give you the Problem Statement; you give us a Launchable, Compliant Product - and keepit that way.You are not responsible for high-level portfolio strategy or deciding what market we enter next. Instead, youare the Solution Architect for your assigned product. You take a clinical goal and autonomously drive everystep required to turn that goal into reality - covering solution discovery, design, regulatory safety,commercial readiness, and post-market monitoring.ResponsibilitiesYou own the entire solution lifecycle (ISO 13485), including SW lifecycle (IEC 62304), from concept toreal-world performance:Solution Design & UXWorkflow Architecture: Design the end-to-end workflow to ensure the solution solves the problem without creating new friction for the users (radiologist, orthopedic, OEM manufacturer, ...).Prototyping: Take ownership of the visual and functional design (wireframes, mockups) to validate the solution before engineering writes a single line of code. (Formative Testing)Solution Discovery: Create solution packages and pitch to prospective customers to find out which combination of features to stage for which releaseRequirements EngineeringSpec Ownership: Translate solution designs into rigorous, unambiguous requirements and user stories (IEC Technical Feasibility: Work directly with an AI and a SW developer to make trade-offs between "perfect UX" and "technical reality."Risk & ComplianceRisk Management (optional if you have the qualification, ISO 14971, EN 82304): You are the Risk Owner. Identify hazards, document them, and define software mitigations.Validation & Pre-Market EvaluationValidation Planning: Design tests that prove your solution actually solves the original problem.Performance Evaluation: Draft and execute final usability studies to clear the product for releaseClinical Evaluation: Ensure the product generates the necessary data to support your Clinical Evaluation Report (CER) and marketing claims (MDR Article 61)Post-Market Surveillance & PMCFActive Monitoring (PMS): Once the product is live, you don't walk away. You analyze real-world usage data, customer complaints, and service reports to detect safety signals or performance drifts.PMCF Strategy: Define and execute Post-Market Clinical Follow-up activities. You determine what data we need to collect from live users to re-confirm the clinical benefit and safety year over year.Feedback Loops: Feed insights from the market (e.g., "Radiologists are ignoring this alert") back into the risk file and the roadmap for the next version.Commercial EnablementSales Readiness: Create demo scripts, battle cards, and value argumentation for the sales team.Launch Training: Train the commercial organization on the solution's USP and workflow.QualificationsMission-driven and passionate about improving healthcare outcomesPragmatic and comfortable stretching outside their roleYou are outgoing and speak "Radiologist," "Developer," and "Sales" fluently.3+ years professional experience in Product Management or Product Ownership, specifically within the MedTech, Digital Health, or Life Sciences industry.Regulatory Knowledge: Proven experience working under ISO 13485 and IEC 62304 and familiaritywith MDR (EU) 2017/745 are a plus.What we offerExciting and open work environment in an internationally growing Health-AI start-upFull-time employment at our Vienna HQ with the possibility of flexible working hoursDiversified and challenging tasks with personal-responsibility of projects and tasksPossibility to participate in internal and external education programsContactSend your CV to The company is located close to the U4-station Unter-St.-Veit: Zehetnergasse 6/2/2, 1140 Vienna, AustriaShow more Show less