Senior engineering leadership for regulated healthcare systems.
Transvolve supports organisations building and operating complex, safety-critical and regulated systems—medical devices, healthcare software, AI-enabled workflows, embedded platforms, secure connectivity, and cloud engineering.
Founder-led consultancy • Senior, hands-on delivery
Professional summary
The work is regulation-first and engineering-led: translating intent into requirements, building coherent architectures, integrating risk controls, and producing verification evidence that supports confident release decisions.
Experience spans embedded and software engineering, data and AI integration, cloud platforms, cybersecurity considerations, QA/regulatory interfaces, and leadership of cross-functional teams.
Operating philosophy
Safety and evidence
Build artefacts as you deliver—traceability and design rationale should not be reconstructed under pressure.
Pragmatism
Only add process when it reduces risk or increases clarity. Remove ceremony that does not produce evidence.
Clarity and collaboration
Make boundaries, interfaces, and decisions explicit so cross-disciplinary teams can execute without ambiguity.
How engagements typically run
1) Rapid orientation
Understand intended use, boundaries, current artefacts, delivery constraints, and the risk profile.
2) Define the evidence path
Agree traceability model, quality gates, and what “release-ready” means for your context.
3) Deliver with the team
Hands-on leadership: architecture, governance, verification strategy, and pipeline improvements—embedded into delivery.
4) Leave capability behind
Templates, patterns, and practices the team can sustain—without dependency on external support.
For the detailed model, see Regulated Delivery Approach.