Internship R&D Engineer Medical Device Jobs in Raleigh, NC

Oracle Health is seeking a Senior Product Manager to drive product management, regulatory and medical device documentation, cross‑functional delivery, and software development lifecycle across Oracle Health’s medication process portfolio. This role will help ensure that medication process products are designed, documented, delivered, and governed with the rigor required for patient safety, regulatory requirements, and medical device software. Our medication process portfolio plays a critical role in connecting ordering, verifying, dispensing, administration, drug content, and clinical workflow transformation across the healthcare ecosystem.

The ideal candidate combines strong product management judgment, product operations discipline, medical device submission or regulatory documentation experience, and technical program management skills. They will work across product management, engineering, clinical informatics, regulatory, legal, privacy, security, quality, UX, data science, release management, and executive stakeholders to strengthen how Oracle Health defines, tracks, documents, and delivers product work in a highly regulated healthcare environment.

This is a highly visible execution and operations role responsible for turning complex, ambiguous, cross‑functional initiatives into clear plans, accountable owners, high‑quality documentation, release‑ready deliverables, and repeatable operating practices that scale across the Pharmacy portfolio.

• 5+ years of experience in product management, product operations, technical program management, regulatory program management, release management, delivery management, healthcare technology product delivery, or related roles.
• Experience working in healthcare technology, regulated software, medical device software, clinical software, EHRs, pharmacy systems, or complex enterprise software environments.
• Experience supporting or leading medical device documentation, regulatory documentation, technical documentation, conformity assessment readiness, clinical evaluation support, safety and performance documentation, or related compliance activities.
• Experience with healthcare regulatory requirements, including FDA, EU MDR, HIPAA, NCPDP, clinical safety, privacy, security, and regulated healthcare delivery.
• Experience partnering with product, engineering, design, QA, regulatory, legal, clinical, privacy, security, delivery, and business stakeholders.
• Demonstrated ability to turn ambiguous requests into structured plans, owners, milestones, work items, risks, decisions, and executable follow‑through.
• Strong organizational skills, attention to detail, and ability to manage multiple complex initiatives simultaneously.
• Ability to communicate priorities, tradeoffs, risks, dependencies, and decisions clearly to technical, clinical, regulatory, business, and executive audiences.
• Strong business judgment and ability to provide thoughtful recommendations when product, regulatory, technical, or customer priorities compete.

• Experience with medical device submissions, medical device classification, software as a medical device, conformity assessment, notified body interactions, technical file preparation, clinical evaluation, safety and performance requirements, or post‑market documentation.
• Experience defining or supporting product requirements, user stories, acceptance criteria, release plans, operational processes, governance routines, or SDLC documentation.
• Strong understanding of software development lifecycle practices, release readiness, documentation governance, and cross‑functional delivery.
• Experience supporting release governance, product readiness, regulatory readiness, documentation workflows, launch readiness, or customer‑facing release preparation.
• Familiarity with Agile, Scrum, Kanban, scaled delivery models, or complex enterprise SDLC frameworks.
• Experience building AI‑powered healthcare products, generative AI solutions, conversational AI, clinical decision support tools, or intelligent workflow automation.
• Knowledge of AI/ML development lifecycles, model evaluation methodologies, and responsible AI practices.
• Experience using Jira, Confluence, dashboards, trackers, operational scorecards, or similar systems of record.
• Experience creating Jira dashboards, Confluence pages, release trackers, operational scorecards, decision logs, documentation matrices, or executive‑level status summaries.
• Comfort operating across multiple teams without direct ownership of every product area or deliverable.

The successful candidate is a structured, pragmatic product manager who can operate across product management, product operations, regulatory readiness, and technical program management depending on what the initiative requires. They are able to both complete regulatory product documentation in addition to working across teams to ensure consistency in product and release processes. They understand that healthcare software operates under elevated expectations for quality, safety, documentation, traceability, release discipline, and customer trust.