Systems Engineering · Process Methodology · Regulated Industries

Transforming how regulated industries build products

30 years at the intersection of systems engineering, lean-agile methods, and digital transformation — from Deming and Senge at Ford in the 1990s to AI-augmented product development today.

About

I help organizations in automotive, aerospace & defense, and medical devices build better products faster — without sacrificing compliance or quality.

My career began at Ford Motor Company in the early 1990s, where I had the rare opportunity to work alongside W. Edwards Deming and Peter Senge during the formative years of systems thinking in manufacturing. That foundation — statistical process control, learning organizations, and systems dynamics — still underpins everything I do.

Since then, I've built deep expertise across Lean, Agile, and Systems Engineering. I studied Lean/Shingo principles with Peter Gaa, learned Scrum directly from Ken Rubin, and developed flow-based metrics approaches informed by Daniel Vacanti's Actionable Agile work. These aren't credentials I collect — they're tools I synthesize into practical solutions for regulated environments.

Today I lead thought leadership in Industry X Engineering, focused on regulated product development across automotive, aerospace & defense, and medical devices. I lead the Americas practice for Codebeamer/ALM and systems-software modeling, helping organizations navigate the transition to software-defined products while maintaining ASPICE, ISO 26262, and other regulatory compliance.

Industry Focus

Automotive Aerospace & Defense Medical Devices Software-Defined Vehicles

Methodology Lineage

Deming Senge Lean/Shingo Scrum Flow Metrics ASPICE

Based In

Naples, Florida

Expertise

Where I create value

ASPICE Assessment & Coaching

Provisional ASPICE assessor with deep experience guiding organizations from Level 0 to Level 2+ across embedded software and systems engineering processes. Proven coaching methodology that delivers 3× industry-standard improvement rates.

Software-Defined Vehicle Development

End-to-end expertise in the transformation from mechanical to software-defined products. From architecture and requirements through continuous integration, deployment, and compliance — bridging the gap between Silicon Valley speed and automotive rigor.

ALM Transformation

Design, deployment, and optimization of Application Lifecycle Management toolchains centered on PTC Codebeamer and Pure Variants. Americas practice lead with implementations spanning automotive, aerospace & defense, and medical devices.

Lean-Agile in Regulated Environments

Deep expertise in making agile methods work where compliance, safety, and traceability are non-negotiable. Evolved well beyond frameworks to flow-based, AI-augmented approaches purpose-built for regulated product development.

Systems Engineering & Process Architecture

Rooted in classical systems engineering and systems thinking (Deming, Senge), with modern application to digital engineering, MBSE, and model-based approaches. Architecture of development processes, not just products.

AI-Augmented Product Development

Pioneering the integration of AI into regulated development workflows — from AI-assisted requirements analysis to automated compliance checking. Rethinking organizational design for the age of AI co-workers.

Methodology

Frameworks forged in practice

After three decades of applying — and outgrowing — existing frameworks, I've synthesized what actually works in regulated product development into two complementary approaches.

L

LASER DOMe

Lean + Agile + Systems Engineering + Regulated · Digital Operating Model

LASER DOMe is a digital operating model purpose-built for organizations developing complex, regulated products. It integrates the best of Lean thinking, Agile delivery, and classical Systems Engineering into a coherent framework that doesn't sacrifice compliance for speed — or speed for compliance.

Unlike framework-first approaches, LASER DOMe starts from the regulatory and safety constraints of your industry (ASPICE, ISO 26262, DO-178C, IEC 62304) and builds the minimal effective process to satisfy them while maximizing flow.

Core Principles

L
Lean

Eliminate waste in development processes, optimize value streams

A
Agile

Iterative delivery with fast feedback, adapted for regulated contexts

S
Systems Engineering

Rigorous architecture, requirements, and V&V — done right

E
Engineering

Technical excellence as the foundation, not an afterthought

R
Regulated

Compliance by design, not compliance by ceremony

F

FLOWCraft

Flow-based Product Development Practice

FLOWCraft is a practice — a methodology and a verb — for applying flow-based thinking to product development. Where LASER DOMe defines the operating model, FLOWCraft is how you execute within it.

Rooted in the work of Deming (statistical process control), Senge (systems thinking), Reinertsen (flow economics), and Vacanti (flow metrics), FLOWCraft replaces project-centric ceremony with continuous flow of value through the development system.

The methodology weaves four threads — Method, Motivation, Role, and Tool — into a coherent fabric that adapts to your organization's regulatory context, technical maturity, and cultural readiness.

Intellectual Lineage

1990s

Deming & Senge at Ford

Statistical thinking and learning organizations

2000s

Lean/Shingo via Peter Gaa

Value stream optimization and continuous improvement

2000s

Scrum via Ken Rubin

Iterative development and team self-organization

2010s

Flow metrics via Vacanti lineage

Data-driven flow management replacing estimation

2020s

AI-augmented development

Rethinking roles, coordination, and process for AI co-workers

Results

Outcomes that matter

Featured Engagement

Near ASPICE Level 2 in 8 Months

Led a coaching engagement combining ASPICE co-assessment with process coaching using the LASER DOMe methodology. Guided a major tire manufacturer's connected product team from baseline to near-ASPICE Level 2 compliance in 8 months — approximately 3× the typical industry improvement pace. The approach demonstrated that rigorous process improvement and delivery velocity aren't opposing forces when the methodology is right.

Industry improvement rate

8 mo

To near-Level 2

Zero→Active

Americas Codebeamer practice

Automotive OEM — Software-Defined Vehicles

Multiple engagements spanning software-defined vehicle strategy, ASPICE implementation, and ALM toolchain transformation. Deep institutional knowledge across global automotive programs.

Aerospace & Defense

Regulated development methodology applied to mission-critical systems, bridging commercial agile practices with DO-178C and defense acquisition requirements.

Medical Devices

Medical device development process transformation, applying LASER DOMe principles within IEC 62304 and FDA regulatory constraints for life-critical embedded software.

Autonomous Vehicle Development

Level 4 autonomous vehicle development approach, applying advanced systems engineering methodology to the most complex challenges in software-defined vehicle architecture.

Contact

Let's talk

Whether you're navigating an ASPICE assessment, planning an ALM transformation, or rethinking your development process for software-defined products — I'd welcome the conversation.