{"id":282251,"url":"https://alion.io/job/oracle-principal-technical-curriculum-developer-samd-product-development-qa","title":"Principal Technical Curriculum Developer – SaMD Product Development & QA","company":{"id":53,"name":"Oracle","domain":"oracle.com","url":"https://alion.io/company/oracle","size_band":"5000+","is_staffing_agency":false,"is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"A","score":92,"open_postings":202,"ghost_share":0,"stale_share":0.505,"repost_share":0,"time_to_fill_p50_days":4,"computed_at":"2026-09-24T05:45:00Z"}},"role":"Education","role_family":"Education","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":91400,"max":187000,"currency":"USD","period":"year","gross":null,"usd_annual":187000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[],"status":"live","first_seen_at":"2026-07-24T00:00:00Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-09-24T17:48:26Z","board_verified":true,"closed_at":null,"days_open":62,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":62},"description":"We are seeking a highly experienced Principal Technical Learning Consultant to help design, build, and lead the next generation of learning programs that enable teams to develop safe, compliant, and effective medical device software.\nThis is not a traditional training or curriculum development role.\nWe are looking for someone who understands how regulated healthcare software is actually developed and can translate complex regulatory, quality, systems engineering, risk management, and product development concepts into practical, role-based learning experiences for engineers, product managers, TPMs, systems engineers, quality professionals, and development leaders.\nThis role will play a critical part in establishing an embedded learning function supporting more than 10,000 product development professionals across Oracle Health.\nWhat You'll Do\nBuild Product Development Learning Programs\nDesign and deliver instructor-led, workshop-based, virtual, and self-paced learning programs supporting Oracle Health's regulated product development organizations.\nCreate onboarding, role-based learning paths, technical workshops, certifications, and continuous education programs.\nDevelop scalable learning strategies that improve competency, productivity, compliance, and execution quality.\nConduct learning needs assessments and partner with leadership to identify capability gaps and organizational priorities.\nTeach Teams How to Build Regulated Medical Devices\nDevelop and deliver learning experiences focused on:\nSoftware as a Medical Device (SaMD)\nMedical Device Development Lifecycle\nDesign Controls\nRequirements Engineering\nSystems Engineering\nTraceability Management\nRisk Management\nHazard Analysis\nFMEA\nFault Tree Analysis\nHAZOP\nVerification & Validation\nSoftware Anomaly Management\nChange Control\nTechnical File Creation & Maintenance\nSubmission Readiness\nAudit Readiness\nRegulatory Documentation\nAI Governance and Responsible AI Development\nProduct Development Processes and Tooling\nPartner Across Product Development\nWork closely with Engineering, Product Management, Quality, Regulatory Affairs, Clinical Safety, Cybersecurity, Human Factors, TPMs, and Compliance teams.\nCollaborate with subject matter experts to transform complex technical knowledge into practical learning experiences.\nSupport adoption of new tools, processes, standards, and methodologies across development organizations.\nBuild learning content that enables teams to effectively perform regulated development activities within Oracle's Quality Management System.\nSupport SaMD and Regulatory Excellence\nHelp teams understand how to operationalize and comply with:\nIEC 62304 - Medical Device Software Lifecycle Processes\nIEC 82304 - Healthcare Software Safety and Security\nISO 13485 - Medical Device Quality Management Systems\nISO 14971 - Risk Management for Medical Devices\nIEC 62366 - Usability Engineering\nIEC 81001-5-1 - Cybersecurity for Health Software\nISO/IEC 27001 - Information Security\nISO/IEC 42001 - AI Management Systems\nFDA Software Guidance\nEU MDR / IVDR\nIMDRF SaMD Frameworks\nDevelop Modern Learning Solutions\nCreate instructor-led training, workshops, simulations, labs, job aids, videos, eLearning modules, process guides, and certification programs.\nDevelop case studies, real-world scenarios, and hands-on exercises that help teams apply learning directly to their day-to-day work.\nMeasure learning effectiveness through assessments, feedback, business outcomes, and adoption metrics.\nContinuously improve learning content based on learner feedback, audit findings, process improvements, and organizational priorities.\n Required Qualifications\nBachelor's degree in Engineering, Computer Science, Healthcare Technology, Regulatory Affairs, Quality, Education, Instructional Design, or related field.\n8+ years of experience in medical device software, healthcare technology, quality engineering, systems engineering, regulatory affairs, product development, technical program management, or technical learning.\nExperience working in regulated industries, preferably healthcare, medical device, or Software as a Medical Device (SaMD) environments.\nStrong understanding of software development lifecycle processes.\nDirect experience with one or more of the following:Requirements engineering\nRisk management\nHazard analysis\nTraceability\nVerification and validation\nTechnical documentation\nDesign controls\nQuality systems\n\nExceptional communication, facilitation, and presentation skills.\nAbility to influence highly technical audiences across multiple organizations.\nPreferred Qualifications\nExperience with IEC 62304, IEC 82304, ISO 13485, ISO 14971, IEC 62366, IEC 81001-5-1, or related healthcare regulations and standards.\nExperience supporting regulatory submissions, audits, notified body reviews, or quality system inspections.\nExperience building and maintaining Design History Files, Technical Files, risk management files, or regulatory evidence packages.\nExperience teaching, coaching, onboarding, mentoring, or facilitating technical workshops.\nFamiliarity with cloud-native healthcare software development environments.\nExperience supporting AI-enabled healthcare products and responsible AI development practices.\nExperience developing learning content for engineers, TPMs, product managers, quality professionals, or technical teams.\nKnowledge of adult learning principles, instructional design methodologies, and modern learning technologies.\nIdeal Candidate Profile\nThe ideal candidate is a former Systems Engineer, Quality Engineer, Design Assurance Engineer, Regulatory Affairs Specialist, Technical Program Manager, Product Development Leader, Clinical Safety professional, or Medical Device Software Engineer who has a passion for helping others learn.\nThis individual understands not only what regulatory standards require, but how teams perform the actual work.\nThey can confidently stand in front of engineers, product managers, TPMs, quality leaders, and executives and teach:\nHow to create and maintain a compliant technical file.\nHow to perform hazard analysis and risk management activities.\nHow to establish traceability across the SDLC.\nHow to evaluate software anomalies from a patient safety perspective.\nHow to prepare evidence for audits and submissions.\nHow to build compliant AI-enabled healthcare products.\nHow to operationalize quality, safety, cybersecurity, and regulatory requirements within modern cloud-native software development environments.\nSuccess in this role requires a unique combination of technical depth, systems thinking, regulatory knowledge, learning expertise, and organizational influence.\nDisclaimer:Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.\nRange and benefit information provided in this posting are specific to the stated locations only\nUS: Hiring Range in USD from: $91,400 to $187,000 per annum. May be eligible for bonus and equity.\nOracle 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.\nCandidates are typically placed into the range based on the preceding factors as well as internal peer equity.\nOracle US offers a comprehensive benefits package which includes the following:\n1. Medical, dental, and vision insurance, including expert medical opinion\n2. Short term disability and long term disability\n3. Life insurance and AD&D\n4. Supplemental life insurance (Employee/Spouse/Child)\n5. Health care and dependent care Flexible Spending Accounts\n6. Pre-tax commuter and parking benefits\n7. 401(k) Savings and Investment Plan with company match\n8. 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.\n9. 11 paid holidays\n10. 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.\n11. Paid parental leave\n12. Adoption assistance\n13. Employee Stock Purchase Plan\n14. Financial planning and group legal\n15. Voluntary benefits including auto, homeowner and pet insurance\nThe role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.\nCareer Level - IC4","description_format":"text","description_chars":8953,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Life insurance","Parental leave","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cloud Computing","Enterprise Resource Planning (ERP)","Database Management","Security Compliance"],"lifecycle":[{"event":"open","at":"2026-09-05T13:32:01Z"},{"event":"reopen","at":"2026-09-23T22:30:32Z"}],"liveness":{"score":5,"band":"cold","label":"Long shot","p_open":1,"p_active":0.185,"p_room":0.28,"age_days":62,"expected_fill_days":4,"reasons":["conf:4","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-09-24T05:45:00Z"},"pay":{"stated_usd_annual":187000,"is_top_pay":true},"html_url":"https://alion.io/job/oracle-principal-technical-curriculum-developer-samd-product-development-qa","json_url":"https://alion.io/job/oracle-principal-technical-curriculum-developer-samd-product-development-qa.json","meta":{"generated_at":"2026-09-24T18:13:15Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}