Product Owner — Medical Device Software

AIATELLA; Helsinki; On-site; EUR 70,000 - 110,000; Full time

Job summary

AIATELLA is seeking a Product Owner to own our medical device software and its regulatory documentation. You will manage design controls and prepare EU MDR and FDA submissions, while connecting clinical and technical teams to align roadmaps.

You will lead PMS and release documentation, support post-market surveillance, and drive prioritisation across ML, backend and frontend development. On-site presence in Helsinki is required.

Qualifications

• PO experience with regulated medical device software
• Experience writing technical documentation for medical devices
• Familiar with IEC 62304, ISO 13485, ISO 14971 and EU MDR controls
• Experience collaborating with clinicians
• Strong technical writing skills and attention to detail

Responsibilities

• Own the device's technical documentation: file, DHF, requirements and traceability
• Lead design controls: user needs, design inputs/outputs, verification and validation plans
• Prepare product and software documentation for EU MDR and FDA submissions
• Contribute to risk management (ISO 14971) and usability files (IEC 62366)
• Own PMS documentation: PMS plans/reports, PMCF and safety reporting
• Own release documentation and software change control
• Oversee product pipeline and roadmap across all products
• Bridge clinical and technical teams, translating clinical needs into requirements
• Engage customers, advisors and clinicians to understand needs
• Support founders in prioritising product resources
• Manage feature prioritisation across ML, backend and frontend
• Drive user story creation and sprint planning
• Support pilot sites as the product goes live

Skills

Product ownership

Regulated medical device

Technical writing

Agile development

Stakeholder management

Clinical collaboration

Tools

FastAPI

PostgreSQL

Docker

Kubernetes

CI/CD

Job description

AIATELLA's mission is to tackle cardiovascular disease at every stage. Through the analysis of vascular imaging across CT, MRI and ultrasound, we provide tools to improve the outcomes of people with advanced disease, and to prevent these diseases in the first place.

We are hiring a Product Owner to take ownership of our medical device software and its technical documentation. The primary mandate is to carry the documentation load for regulatory submissions and post-market surveillance as we scale, freeing the founding team to focus on the next generation of products. Beyond that, the role oversees the product pipeline and acts as the connector between our clinical and technical teams.

Primary Mandate

• Own the technical documentation for the device: technical file, design history file, requirements and traceability
• Run design controls in practice: user needs, design inputs and outputs, verification and validation planning, design reviews
• Prepare product and software documentation for EU MDR and FDA submissions, working with our Quality and Regulatory team
• Contribute to risk management (ISO 14971) and usability engineering (IEC 62366) files
• Own post-market surveillance documentation as it scales: PMS plans and reports, PMCF, complaint and vigilance inputs, and periodic safety reporting
• Own release documentation and software change control

Secondary Mandate

• Oversee the product pipeline and roadmap across our products
• Act as the connector between clinical and technical teams, translating clinical needs into requirements engineers can build against
• Engage customers, advisors and clinicians to understand the need behind each product
• Support the founders in prioritising which products to resource
• Manage feature prioritisation and scope across our ML, backend and frontend teams
• Drive user story creation and refinement, and facilitate sprint planning and product demos
• Support our pilot sites as the product goes live

Requirements

• Experience as a Product Owner on software as a regulated medical device
• Hands-on experience writing technical documentation for a medical device
• Practical knowledge of IEC 62304, ISO 13485, ISO 14971 and EU MDR design controls
• Familiarity with post-market surveillance obligations under EU MDR
• Experience working directly with clinicians
• Strong track record delivering complex technical products
• Excellent technical writing and documentation skills
• Enough technical depth to discuss trade-offs with ML and backend engineers
• Experience with agile development practices
• Able to attend on-site in Helsinki

Nice To Have

• Experience with medical imaging, DICOM or PACS integration
• Class IIa or higher device experience
• Experience with an FDA 510(k) or De Novo submission
• Knowledge of AI/ML regulatory considerations such as GMLP and algorithm change protocols
• Experience with an electronic QMS
• Background in life sciences, biomedical engineering or clinical practice'

Company Tech Stack

• Backend: Python (FastAPI), PostgreSQL, Redis
• ML/AI: PyTorch, MONAI, MLflow
• Frontend: React, TypeScript
• Infrastructure: Kubernetes, Docker, CI/CD
• Cloud: Azure (AKS, AML) and GCP
• Performance: C++, CUDA