Clinical Product Manager - Medical Device Safety & Usability

**Job Description** 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 **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 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 disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance 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 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing [email protected] or by calling +1 888 404 2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.