Job Description
Responsibilities: Product Strategy & Vision
* Define and maintain the product vision, ensuring alignment with business objectives, user needs, and regulatory standards.
* Collaborate with engineering, clinical teams, and internal stakeholders to gather requirements and write detailed, actionable feature descriptions for the development teams.
Agile Execution
* Participate in backlog grooming, sprint planning, and other Agile ceremonies.
* Write technical features with functional acceptance criteria to guide development.
* Provide feedback during sprint reviews and demos to ensure quality, usability, and compliance.
Stakeholder Collaboration
* Support human factors and usability testing against clinical workflows and safety requirements.
* Coordinate dependencies across projects and teams to ensure timely delivery.
Regulatory & Compliance
* Collaborate with regulatory and quality teams to ensure adherence to standards such as IEC 62304, ISO 14971, and 21 CFR Part 820.
* Contribute to documentation and processes required for regulatory submissions and audits.
Culture & Values
* Uphold the Companys core values of Integrity, Innovation, Accountability, and Teamwork.
* Demonstrate behaviour consistent with the Companys Code of Ethics and Conduct.
* Duties may be modified or assigned at any time to meet the needs of the business.
Required:
* Bachelors degree in engineering, Computer Science, medically related field; or equivalent experience.
* 4+ years of experience as a Technical Product Owner or Project Manager in an Agile software development environment.
* Experience in medical device development under Design Control (21 CFR Part 820), IEC 62304, and ISO 14971.
* Proven ability to collaborate across cross-functional teams and influence stakeholders in a matrixed organisation.
* Strong written and verbal communication skills.
* Ability to manage complex, interdependent projects with multiple stakeholders.
Preferred
* Clinically relevant field experience. Patient monitoring experience is preferred.
* Experience with usability testing and human factors engineering.
* Experience with tools such as Jira, Confluence, Figma, or Azure DevOps.
Additional Requirements
* Willingness to travel domestically and internationally (up to 15%).
* Ability to work across global time zones (e.g., NA, EMEA, APAC) as needed.
* Must be able to obtain necessary documentation for international travel.
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