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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