The Problem
The health-tech startup was rapidly innovating in the development of advanced, task-specific language models for healthcare diagnostics and digital therapeutics. But as engineering output accelerated, the company lacked the operational backbone necessary to:
Scale product development in a structured, repeatable, and compliant manner
Manage cross-functional coordination between engineering, product, clinical experts, and leadership
Ensure quality, safety, and regulatory compliance (HIPAA, SOC 2, FDA, ISO) from the earliest stages
Establish consistent processes for planning, reporting, performance management, training, onboarding, and risk mitigation
Translate strategic business goals into actionable engineering and product plans
Maintain visibility into velocity, resourcing, KPIs, and release readiness
Prepare for growth, audits, and future medical device regulatory pathways
Without a strong operational foundation, the company risked inefficiency, compliance gaps, duplicated effort, and delays in delivering clinically reliable AI-driven therapeutics.
The Solution
Built an Operational Framework for the Organization
Developed operational strategies aligned with company OKRs and translated them into actionable plans across engineering, product, and implementation teams.
Created scalable systems for execution, communication, reporting, and accountability across the company.
Designed and implemented engineering and operations metrics, dashboards, and reporting cadences (weekly, monthly, quarterly, post-release).
Established Scalable Product & Engineering Operations
Implemented Scrum and Agile delivery as the foundational development methodology.
Built and administered the Jira ecosystem: epics, stories, tasks, workflows, filters, and dashboards, ensuring engineering work was structured around company goals.
Designed and maintained product requirement documents, user flows, WBS structures, context diagrams, and the full product roadmap and release schedule based on velocity and capacity.
Implemented sprint ceremonies and created structured release management processes.
Built Quality, Performance, and Strategic Planning Frameworks
Created a complete framework including self-evaluations, performance reviews, professional development plans, supervisor training, employee feedback loops, onboarding and offboarding workflows, and a worker recognition program.
Ensured all personnel met required training requirements and professional development targets.
Acted as Compliance & Privacy Officer, overseeing HIPAA and SOC 2 programs, audit readiness, and ongoing compliance checks.
Analyzed FDA, ISO, HIPAA, and SOC 2 regulations and used them to build a comprehensive Quality Management System (QMS)
Established cross-functional QA processes to maintain product safety, accuracy, and clinical reliability.
Risk identification and mitigation
The Outcome
Clear operational structure replaced ad-hoc processes, enabling predictable execution and coordinated work across engineering, product, clinical, and implementation teams.
Increased velocity and efficiency, supported by formalized Agile workflows, roadmap planning, and structured backlog management.
Improved quality and safety through structured QA processes, documentation standards, release procedures, and a comprehensive QMS.
Successful audit readiness for SOC 2 and HIPAA due to mature compliance processes and documentation (Q1 2026).
Stronger alignment between business goals and engineering output, supported by transparent metrics, dashboards, and reporting systems.
Reduced operational risk, backed by proactive risk assessments, mitigation plans, and compliance checks.
A professionalized employee experience from onboarding to performance management, creating stronger accountability and role clarity.
A scalable organizational foundation, positioning the company for future FDA engagement, larger releases, and clinical partnerships.
Knowledge, Skills, and Abilities
Program & Project Management
Strategic planning and operational design
Cross-functional project coordination
Timeline, milestone, and roadmap management
Agile/Scrum facilitation and sprint management
Product & Engineering Operations
Jira administration, workflow design, reporting, dashboard creation
PRDs, user stories, user flows, WBS planning, release schedules
Engineering metrics and analytics
QA process establishment and documentation
Regulatory & Quality Management
HIPAA, SOC 2, FDA, and ISO frameworks
QMS development and compliance systems
Document management, audit procedures, record control
Risk management and mitigation
People & Organizational Development
Performance management systems
Training and development program creation
Onboarding/offboarding design
Leadership communication and stakeholder alignment
Operational Excellence
Process design and improvement
Data analysis, reporting, and dashboard development
Administrative coordination across the organization
Scalable systems thinking and operational architecture
