Product Owner — Medical Device Software

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