Specialized Medtech Consulting
Manufacturing & Test Systems for Class III Devices, from Development to Validated Production.
Experience with implantable neuromodulation systems
Supported devices through FDA/TÜV audit readiness
I help medtech teams move from development into validated production - reducing audit risk, fixing test bottlenecks, and accelerating EVT through PVT.
Built production test systems deployed in validated manufacturing environments”
Get senior manufacturing support , without adding headcount
I support specific phases or high-risk areas without the overhead of a permanent hire
Remote-first support aligned with US and Australian teams
Short-term or project-based engagements
Interim support during scale-up or validation pressure
Advisory support during critical EVT, DVT or PVT transition
Where teams get stuck
Most programs don’t fail in development - they fail when production exposes what wasn’t built properly.
This is where timelines slip, audits fail, and scale becomes expensive to fix.
Test systems aren’t
production-ready
Fixtures, automation, limits, and data pipelines often lag behind the device program.
Data doesn’t support
decisions
Cp/Cpk, yield, limits, and outlier handling need structure before production pressure hits.
Validation exposes
weak processes
Manufacturing processes need to hold up under repeatability, traceability, and scrutiny.
Audit readiness
comes too late
Documentation and evidence gaps become expensive when they appear at the wrong time.
How I Help
Focused support for high-risk transition points between development, manufacturing, validation, and audit readiness.
Manufacturing Readiness
Identify what will fail during validation - before it does
Test Systems
Build test systems that survive validation and scale
Audit & Compliance
Prepare your system to pass audit - not just documentation review
Yield & Failure Analysis
Find and fix the issues that will kill yield at scale
Used in real production and audit-critical programs
“Mark consistently delivered production-ready test and manufacturing solutions under real constraints.”
Over more than a decade, he built scalable test systems and data analysis frameworks that supported high-volume manufacturing and product launches - even during periods of significant team downsizing.
His ability to execute under pressure while maintaining technical depth is rare.
Director, Reliability Engineering, Advanced Bionics
“Mark was our go-to SME for regulatory audits and validated environments.”
He consistently delivered high-quality solutions across software, test, and manufacturing, with deep understanding of processes, standards, and compliance expectations.
He was trusted by both engineering and quality teams in high-stakes audit situations.
Lead, AI Solutions & Architecture (Life Sciences / GxP)
“Mark was a trusted leader across engineering and cross-functional teams.”
He consistently balanced delivery with team effectiveness, and was relied on to resolve complex issues across groups.
His ability to align people while maintaining execution made him highly effective in scaled environments.
CHRO, Advanced Bionics
I’m a Senior R&D / Manufacturing Engineer with over a decade of experience bringing Class III implantable medical devices into production.
My focus is on test systems, validation, and ensuring products meet real manufacturing and regulatory conditions. I’ve worked closely with US-based teams and understand the challenges of scaling complex devices under real-world constraints.