What You’ll Do
* Own and refine the product vision, ensuring alignment with user needs, business goals, and regulatory expectations.
* Translate complex requirements into clear, actionable features for engineering teams.
Agile Delivery
* Lead backlog refinement, sprint planning, and Agile ceremonies.
* Write high‑quality technical features and acceptance criteria.
* Provide continuous feedback to ensure quality, usability, and compliance.
Cross‑Functional Collaboration
* Work closely with clinical, engineering, and quality teams.
* Support usability and human factors testing aligned to clinical workflows.
* Manage dependencies across multiple teams and projects.
Regulatory & Compliance
* Partner with regulatory teams to ensure adherence to standards such as IEC 62304, ISO 14971, and 21 CFR Part 820.
* Contribute to documentation for audits and regulatory submissions.
What You Bring
* Degree in Engineering, Computer Science, or a healthcare‑related field (or equivalent experience).
* 4+ years as a Technical Product Owner or Project Manager in Agile software environments.
* Experience working with regulated medical device development under Design Control.
* Excellent communication skills and the ability to influence across matrixed teams.
* Strong organisational skills and comfort managing complex, interdependent projects.
* Experience in clinical environments (patient monitoring is a plus).
* Knowledge of usability testing and human factors engineering.
* Familiarity with tools like Jira, Confluence, Figma, Azure DevOps.
* Travel up to ~15% (domestic & international).
* Must be eligible for international travel documentation.
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