Digital Product Owner – Patient Find and Diagnose

Role Summary

Digital Product Owner – Patient Find and Diagnose. Location: Cambridge, MA.

Responsibilities

• Define and communicate a clear digital product roadmap aligned with business objectives to accelerate patient identification and diagnosis solutions enabling the access to optimal therapy faster.
• Lead product definition, development, deployment, and life cycle management activities for disease diagnostic solutions including complex algorithms or AI / ML models that can be accessed seamlessly, ensuring compliance with regulations, standards, and customer needs.
• Serve as the product owner for a scrum team developing the product, refining requirements, and setting priorities throughout the life cycle management of the product from inception to launch to adoption.
• Represent the product voice for all its labeling, risk management activities, human factor studies (as applicable), customer training, and related post-market surveillance activities.
• Collaborate with stakeholders and manage expectations on product development and deliveries. Engage with cross-functional teams (business, commercial, medical affairs, clinical affairs, cybersecurity, privacy, pharmacovigilance, legal team and more) to deliver safe and effective products that excel in performance and usability.
• Monitor and analyze product performance to assess solution effectiveness and drive product adoption in the field.
• Stay informed about the latest advancements in patient find and diagnostic technologies, incorporating innovative approaches and best practices to maintain a competitive edge.
• Collaborate with cross-functional teams to prepare for regulatory inspections and internal audits, ensuring compliance and addressing findings through corrective and preventive actions.

Qualifications

• Bachelor‚Äôs degree
• 10+ years of experience of being a Software Product Owner
• Strategic thinker, Business acumen, exceptional communication, and leadership skills
• Advanced skills in Agile practices, digital strategy, product management, project management, compliance, and business acumen
• M.S in Computer Science, Information Systems, or MBA (Preferred)
• 5+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software development, regulatory submissions, and launch (Preferred)
• Having knowledge of EHR and Health System integrations (Preferred)
• Technical knowledge of driving the development and adoption of AI / ML (Machine Learning) solutions in healthcare industry (Preferred)

Skills

• Product ownership in AI/ML enabled healthcare solutions
• Regulatory compliance and risk management
• Cross-functional collaboration and stakeholder management
• Agile methodologies and Scrum leadership

Education

• Bachelor‚Äôs degree required; advanced degree preferred (MBA or MS in CS/IS)