Company Profile
As an internationally expanding Digital Health start-up, we are a leader in the field of AI-powered analysis of
imaging data for orthopedics and radiology. Our vision is to leverage AI solutions to enable early diagnosis
and to measurably improve surgical success and patient outcomes. You are energetic, curious but also
persistent? Then you are exactly right to bring in your skills to push our further expansion We offer an
attractive workplace in an agile, fast-growing company and an open communication and corporate culture.
The Tasks
We are looking for a Product Manager with strong PO execution skills to bridge the gap between clinical
needs 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 but
demanding: We give you the Problem Statement; you give us a Launchable, Compliant Product - and keep
it that way.
You are not responsible for high-level portfolio strategy or deciding what market we enter next. Instead, you
are the Solution Architect for your assigned product. You take a clinical goal and autonomously drive every
step required to turn that goal into reality - covering solution discovery, design, regulatory safety,
commercial readiness, and post-market monitoring.
Responsibilities
You own the entire solution lifecycle (ISO 13485), including SW lifecycle (IEC 62304), from concept to
real-world performance:
Solution Design & UX
Workflow 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 release
Requirements Engineering
Spec 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 & Compliance
Risk 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 Evaluation
Validation 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 release
Clinical Evaluation: Ensure the product generates the necessary data to support your Clinical Evaluation Report (CER) and marketing claims (MDR Article 61)
Post-Market Surveillance & PMCF
Active 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 Enablement
Sales 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.
Qualifications
Mission-driven and passionate about improving healthcare outcomes
Pragmatic and comfortable stretching outside their role
You 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 familiarity
with MDR (EU) 2017/745 are a plus.
What we offer
Exciting and open work environment in an internationally growing Health-AI start-up
Full-time employment at our Vienna HQ with the possibility of flexible working hours
Diversified and challenging tasks with personal-responsibility of projects and tasks
Possibility to participate in internal and external education programs
Contact
Send your CV to
The company is located close to the U4-station Unter-St.-Veit: Zehetnergasse 6/2/2, 1140 Vienna, Austria
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