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Required Qualifications:
Licensed clinician (RN, PharmD, MD, NP, PA, or equivalent) with 10+ 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.
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.
. Partner closely with Medical Device Tiger Teams and transition into broader next-generation device initiatives.
Career Level - IC4
Oracle Corporation is an American multinational computer technology corporation headquartered in Austin, Texas.In 2020, Oracle was the second-largest software company in the world by revenue and market capitalization.The company sells database software and technology (particularly its own brands), cloud engineered systems, and enterprise software products, such as enterprise resource planning (ERP) software, human capital management (HCM) software, customer relationship management (CRM) software (also known as customer experience), enterprise performance management (EPM) software, and supply chain management (SCM) software.
Job ID: 131188911
