Work that held up when it had to.

Challenge

A Series B medical device company had been developing a Class II diagnostic software platform for three years without a formal IEC 62304 software lifecycle process. With a 510(k) submission six months out, their existing documentation wouldn't survive FDA review.

Approach

Engaged to restructure the software development lifecycle from the ground up. Established a compliant design history file, implemented risk management per ISO 14971, and built audit trail architecture meeting 21 CFR Part 11 requirements. Worked directly with the regulatory affairs team to align technical documentation to submission requirements.

Outcome

510(k) cleared on first submission with no additional information requests. Software documentation cited by FDA reviewer as complete and well-organized.

Challenge

A fintech firm operating an SEC-registered alternative trading system received an examination finding citing deficiencies in their electronic recordkeeping and audit trail systems. They had 90 days to remediate before a follow-up examination. The platform — used by investment professionals to run multiple regression analytics against historical market data and derive quantitative investment scores — had been built on legacy data infrastructure that predated modern enterprise relational database systems.

Approach

Conducted a full technical assessment of the existing audit trail architecture against SEC Rule 17a-4 and FINRA requirements. Redesigned the event logging system, implemented immutable write-once storage, and built a compliance reporting layer that satisfied both internal audit and external examination requirements. As part of the remediation, migrated the platform's core analytical data layer to a modern enterprise relational database — the first such system in the company — enabling the structured audit trail and query capabilities the compliance architecture required.

Outcome

Remediation completed in 74 days. Follow-up SEC examination closed with no findings. The new relational database foundation became the platform standard, enabling faster analytical query performance and a more maintainable compliance infrastructure going forward.

Challenge

A major global entertainment company needed to maintain and evolve a suite of web applications and operational systems running across multiple theme park properties — including guest-facing applications, internal operations tooling, and software embedded in physical attractions and park infrastructure. The scale, uptime requirements, and physical integration points made this unlike any conventional web platform.

Approach

Led the web engineering team responsible for applications spanning park servers, guest experience systems, and in-park machines and devices. Managed the full lifecycle of both consumer-facing web properties and the operational software running inside the parks themselves — coordinating across infrastructure, attractions engineering, and product teams to keep systems reliable across properties operating 365 days a year.

Outcome

Sustained platform reliability across a global portfolio of theme park properties and guest-facing applications. Operational systems and in-park software maintained continuous uptime through high-attendance events, seasonal peaks, and infrastructure changes — with zero guest-impacting incidents attributable to software failures under our team's ownership.

Challenge

A healthcare software company operating within the medical division of a major media and information corporation had grown its engineering organization without a formal development process. Product delivery was unpredictable, marketing and business stakeholders had no visibility into the roadmap, and the team lacked the structure needed to scale. The VP Engineering role was vacant and the organization needed a reset.

Approach

Brought in as VP Engineering to restructure the department from the ground up. Established a formal software development lifecycle, introduced agile planning practices, and created structured touchpoints that brought marketing and business leadership into the development process for the first time. Rebuilt team accountability, defined engineering career tracks, and aligned delivery cadence to product and commercial goals.

Outcome

Engineering department stabilized and delivery became predictable within two quarters. Cross-functional alignment between engineering, marketing, and business leadership improved release planning and reduced late-stage scope changes. The organization was positioned to scale headcount and product scope without the process debt that had constrained it.