Principal Member of Technical Staff - Medical Device Software

**Job Description** As a Principal Member of Technical Staff, you will be a key contributor to the development of and governing the software architecture and compliance framework for regulated medical devices. This role bridges product development, regulatory, and enterprise architecture functions-ensuring that device software solutions are designed securely, maintain regulatory compliance, and align with enterprise standards and long-term technology strategy. You will guide product teams in interpreting and applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, and support the adoption of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and standards along with a proven experience defining and building secure, complaint and scalable architectures for safety-critical systems is a must. **Responsibilities** **Responsibilities:** As a Principal Member of Technical Staff for Medical Device Software, your key responsibilities include: + Architectural Leadership & Governance + Serve as the designated Enterprise Architect for one or more regulated medical devices, defining the software architecture and integration strategy in alignment with enterprise and product-level requirements. + Define and manage software and system interfaces, ensuring end-to-end traceability from requirements through implementation and verification. + Partner with product and platform teams to ensure software designs are aligned with device-level safety, performance, and compliance needs. + Regulatory Compliance & Quality Alignment + Ensure adherence to medical device software standards including IEC 62304 (software lifecycle) and IEC 82304 (health software product safety and effectiveness). + Embed regulatory and quality requirements into the architecture and development lifecycle, enabling teams to maintain compliance through automated traceability and documentation. + Support audits, technical documentation, and risk management activities by providing architectural artifacts and compliance evidence. + Secure Design & Risk Management + Drive implementation of secure-by-design principles across all device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based Process to ensure consistent evaluation, mitigation, and documentation of software-related risks. + Cross-Functional Collaboration + Partner closely with Regulatory, Quality, and Security teams to align technical and compliance processes with evolving global requirements. + Collaborate with SDLC tooling and DevOps teams to ensure development environments, CI/CD pipelines, and configuration management systems support regulatory traceability and validation. + Provide architectural and compliance mentorship to product teams, enabling them to take ownership of compliant design and documentation practices. + Continuous Improvement + Champion architectural best practices, technical governance, and scalable design patterns across the organization's medical device portfolio. + Identify opportunities to streamline compliance activities through improved tooling, automation, and architectural consistency. **Qualifications:** + Education + Bachelor's or Master's degree in Computer Science, Software Engineering, or a related technical field. + Experience + Minimum of 8+ years of professional software engineering experience, including significant responsibility for designing and governing architectures in complex, safety- or compliance-critical systems (medical device experience preferred). + Technical Expertise + Deep proficiency in Java, Python, or similar object-oriented languages, with proven ability to design and implement secure, scalable, and maintainable systems. + Strong grounding in software engineering fundamentals-including algorithms, data structures, microservices, and RESTful APIs. + Advanced understanding of system and distributed architecture design, including data flow, integration patterns, and fault-tolerance strategies. + Proven ability to define and enforce architecture governance and traceability across the software development lifecycle (SDLC). + Regulatory & Compliance Knowledge + Working knowledge of medical device software standards such as IEC 62304, IEC 82304, and relevant FDA guidance. + Proven ability to apply regulatory requirements to software design, documentation, and development practices. + Experience defining or contributing to compliant SDLC processes, including risk management, traceability, and verification/validation frameworks. + Leadership & Collaboration + Demonstrated ability to influence architectural direction across multiple product teams and ensure alignment with enterprise standards. + Strong communication and documentation skills-capable of clearly articulating complex technical concepts to both technical and regulatory stakeholders. + Track record of mentoring and guiding engineers, fostering adoption of compliant and high-quality software engineering practices. 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: $96,800 to $223,400 per annum. May be eligible for bonus and equity. 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 - IC4 **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.