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Job Description

This highly visible principal individual contributor role requires the ability to move between organizational strategy, engineering detail, and hands-on implementation. You will independently lead ambiguous, cross-functional programs, translate business and regulatory needs into technical requirements, and build tooling that reduces manual work and improves delivery.

You will work closely with Engineering, Product, Quality, Legal, and Regulatory Affairs to integrate medical device requirements into development and operational workflows. A key focus will be using automation to improve requirements tracking, documentation, evidence collection, and readiness for regulatory reviews, audits, certifications, and product releases.

As a strategic partner to the Director of Operations, you will also support organizational planning, resource allocation, and executive decision-making. Success requires technical depth, sound judgment, and the ability to influence senior stakeholders while delivering measurable improvements across teams.

Responsibilities

What You'll Do:

+ Lead Complex Technical Programs: Own cross-functional initiatives from problem definition through implementation. Establish technical requirements, milestones, dependencies, success measures, and accountability across Engineering, Product, Quality, Regulatory, and Operations.

+ Build Automation and Internal Tooling: Design, prototype, implement, and maintain scripts, integrations, dashboards, and workflow applications using Oracle APEX, Python, SQL, APIs, or comparable technologies. Streamline intake, approvals, reporting, and program execution.

+ Apply Codex and AI-Assisted Development: Use Codex and related tools to accelerate automation development, prototyping, testing, and documentation. Review and test generated outputs, applying appropriate controls when tooling supports regulated processes.

+ Connect Automation With Medical Device Compliance: Partner with Quality and Regulatory Affairs to identify opportunities to automate requirements tracking, traceability, evidence collection, change tracking, and readiness reporting. Ensure solutions support applicable documentation, review, and validation requirements.

+ Drive Medical Device Regulatory Readiness: Lead integrated plans supporting medical device certification, regulatory reviews, audits, and international expansion. Translate regulatory and quality requirements into actionable engineering and operational deliverables with clear ownership.

+ Strengthen Technical Documentation: Coordinate Engineering and Product teams to produce complete, consistent, and traceable documentation supporting development, verification and validation, risk management, and product launches.

+ Lead Release Readiness: Drive end-to-end release coordination, including engineering dependencies, quality and regulatory deliverables, readiness criteria, risk resolution, and stakeholder communication.

+ Partner With Operations Leadership: Serve as a strategic thought partner to the Director of Operations. Support OP1/OP2 planning, headcount and capacity planning, investment prioritization, and execution of organization-wide initiatives.

+ Turn Data Into Decisions: Build reliable reporting and analyze engineering, operational, and workforce data to identify bottlenecks, flag risks, and recommend actions. Measure improvements in cycle time, manual effort, delivery predictability, and compliance readiness.

+ Influence Across the Organization: Lead executive discussions, communicate technical tradeoffs clearly, and drive decisions across teams. Establish reusable tools and practices, mentor partners, and build trust while maintaining accountability.

What We're Looking For

+ 8+ years of relevant experience in technical program management, software engineering, systems engineering, or technical operations, including ownership of complex cross-functional programs.

+ Strong hands-on technical capabilities , with demonstrated experience building automation, internal applications, scripts, or systems integrations.

+ Practical experience with Codex or comparable AI-assisted coding tools , including reviewing, testing, and maintaining generated code.

+ Experience with technologies such as Oracle APEX, Python, SQL, REST APIs, version control, and CI/CD workflows .

+ Direct experience working on regulated medical device products , including software-based medical devices or software within medical device systems.

+ Working knowledge of medical device development and quality processes, including requirements traceability, design and development controls, risk management, verification and validation, and change control.

+ Experience translating regulatory and quality requirements into technical plans, operational workflows, and documented evidence.

+ Ability to engage with engineers on system architecture, integration dependencies, implementation tradeoffs, and release risks.

+ Demonstrated experience partnering with VP- and Director-level leaders on planning, prioritization, and execution.

+ Ability to independently structure ambiguous problems, influence decisions across organizational boundaries, and deliver measurable outcomes.

+ Strong analytical skills and the ability to turn complex technical and operational data into clear recommendations.

+ Executive presence, clear communication, and emotional intelligence, with the ability to lead discussions across Engineering, Product, Legal, Regulatory, Quality, and Finance.

Preferred Qualifications

+ Direct experience using Codex to build and maintain internal tooling or engineering automation .

+ Experience automating documentation, traceability, or evidence workflows within a regulated medical device environment.

+ Experience supporting medical device submissions, certifications, regulatory reviews, or audits across multiple markets.

+ Experience assessing and validating tools used in regulated development or quality processes.

+ Experience scaling technical operations and establishing shared tooling across global teams.

Disclaimer:

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.

Range and benefit information provided in this posting are specific to the stated locations only

US: Hiring Range in USD from: $89,000 to $209,500 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 rang...

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