Clinical Product Manager – Medical Device Safety & Usability

Oracle Health is standing up a specialized clinical product management team focused on medical device–aligned 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:

· Licensed clinician (RN, PharmD, MD, NP, PA, or equivalent) with 5+ years of clinical experience.

· Minimum 10+ years’ experience in product management, clinical informatics, or usability/human factors engineering within healthcare technology or medical devices.

· Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD).

· Strong understanding of clinical risk, safety analysis, and usability validation methodologies.

· Proven ability to translate complex clinical workflows into clear design and engineering requirements.

· Excellent cross-functional communication and documentation skills.

Preferred:

· Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.).

· Experience working with AI-driven medical device applications or software as a medical device (SaMD).

· Familiarity with Oracle Health/Cerner Millennium or similar EHR platforms.

· Advanced degree in healthcare informatics, biomedical engineering, or related field.

IC5 - Career Level

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 maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle’s differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.

Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disabi