As a Software Product Owner, you will own the software product backlog and act as the bridge between stakeholders, customers, and the software engineering team. You will translate clinical and operational needs into actionable software requirements and ensure timely and high-quality delivery through Agile / Scrum development processes.
This role combines product ownership, stakeholder management, clinical application understanding, and regulated software documentation coordination. You will work closely with software developers, QA engineers, system engineers, clinical users, and management teams to continuously improve the product and user experience.
Key Responsibilities
Product Ownership & Scrum Management
- Own and manage the software product backlog.
- Gather, refine, and prioritize software requirements together with stakeholders and engineering teams.
- Write detailed user stories, acceptance criteria, and software requirements.
- Lead Agile / Scrum ceremonies including sprint planning, backlog grooming, daily standups, sprint reviews, and retrospectives.
- Make day-to-day prioritization decisions together with the software team.
- Coordinate software releases, feature planning, and roadmap execution.
- Track software progress, risks, and dependencies.
Stakeholder & Clinical Collaboration
- Collect and consolidate feedback from clinicians, distributors, customers, and internal stakeholders.
- Understand clinical workflows and operational pain points to improve product usability and effectiveness.
- Coordinate discussions between technical teams and non-technical stakeholders.
- Support product demonstrations, validation activities, and user acceptance testing.
- Work closely with support and deployment teams to address field issues and product improvement opportunities.
QMS & Regulated Documentation
- Support preparation and maintenance of software-related QMS documents.
- Maintain traceability between software requirements, implementation, testing, and issue tracking systems.
- Coordinate software lifecycle documentation in compliance with internal processes and regulatory requirements.
- Support software change requests, release documentation, and audit preparation activities.
- Work closely with QA/RA teams to support compliance with standards such as ISO 13485 and IEC 62304.
Software Application & Deployment Support
- Support software applications and deployments on customer sites when required.
- Coordinate issue investigations and bug prioritization with engineering teams.
- Help document workflows, operational procedures, and product usage guidelines.
Requirements
- Bachelor's degree in Computer Science, Biomedical Engineering, Information Systems, Engineering, or related field.
- Experience as a Product Owner, Business Analyst, Technical Project Coordinator, or similar role in software development environments.
- Strong understanding of Agile/Scrum software development workflows.
- Experience managing software backlogs and writing user stories.
- Strong communication, stakeholder management, and organizational skills.
- Ability to work effectively in cross-functional and fast-paced environments.
Nice to have:
- Experience in medical device, healthcare technology, or regulated software environments.
- Familiarity with software development lifecycle (SDLC), software testing, and traceability practices.
- Knowledge of QMS processes and software documentation practices.
- Familiarity with Jira, Confluence, GitLab, or similar tools.
- Understanding of medical device regulations and standards such as ISO 13485, IEC 62304, FDA, or HSA guidelines.
- Experience supporting customer deployments or clinical applications is an advantage.
What We Offer
- Opportunity to contribute to impactful healthcare technologies.
- Collaborative and multidisciplinary working environment.
- Exposure to software, AI, robotics, and regulated medical device development.
- Opportunity to work closely with engineering, clinical, and operational teams.
- Meaningful involvement in real-world healthcare applications and product innovation.
