Clinical Product Manager Medical Device Safety & Usability

Clinical Product Manager (Medical Device Focus)

Oracle Health is standing up a specialized clinical product management team focused on medical devicealigned products. This team bridges clinical practice, product strategy, and regulatory engineering to ensure patient safety, usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, usability, and risk management processes. You'll collaborate across engineering, regulatory, and product leadership teams to align development activities with ISO 14971, IEC 62366, and EU / US Clinical Evaluation standards.

Key Responsibilities

• Conduct and contribute to clinical risk analyses (per ISO 14971).
• Collaborate on Failure Mode and Effects Analyses (FMEAs), hazard analyses, and usability studies for clinical safety.
• Partner with engineering teams to identify and mitigate clinical risks across design and implementation.
• Serve as a Clinical and Product-Focused Specialist, providing deep domain expertise in clinical workflows, usability, and patient safety.
• Provide clinical context for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements.
• Oversee usability engineering (IEC 62366), ensuring requirements map to user needs and validation meets usability and human factors standards.
• Lead change management oversight across device-relevant business areas (internal and external), ensuring documentation, communication, and validation of changes.
• Act as a bridge between Product Management, Clinical Safety, and Health Compliance Organizations (HCOs).
• Facilitate regulatory awareness and readiness across the broader product organization.

Qualifications Required

Preferred

Responsibilities

Analyzes business needs to ensure Oracle solution meets customer objectives. Exercises creativity and independent judgment and business acumen in selecting proper methods and techniques to design non-routine and very complex solutions utilizing domain expertise to meet customer needs. As a position of professional influence, this individual frequently operates at the leading edge of their area of expertise. Presents and demonstrates solutions to customers. Builds and maintains a network and up-to-date specific industry or domain knowledge. Leads the domain specific solution design aspects of engagement(s) ensuring high quality and integrated business solutions. Knowledgeable of competition and external factors that may influence Oracle's competitive position. Resolves highly complex customer issues by recommending solutions. Ensures enterprise solution spans across the customer's clinical processes. Designs innovative solutions that maximize the use of standard product capabilities to meet customer objectives.

Disclaimer

Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.

Range and benefit information provided in this posting are specific to the stated locations only US : Hiring Range in USD from : $139,400 to $291,800 per annum. May be eligible for bonus, equity, and compensation deferral. Oracle US offers a comprehensive benefits package which includes the following :

The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC5