• Providing customized Operational Excellence consulting for manufacturing business.• 4OpEx offers the ability to look at your big picture numbers and help you appropriately scope & select products &/or processes for review that will open up a wealth of value opportunities you are currently missing.• Our ability to help you see the "wood from the trees", given our external uncompromising set of eyes plus the experience we bring to help guide, sustain and complete the project, help us deliver un-paralleled results.• Accomplished evaluating and delivering significant sourcing, design and operational savings efficiencies, focusing upon Automotive, Defense, Aerospace, Oil & Gas and Rail Transportation Fortune 500 companies globally.• Skilled at reviewing current business metrics, product design, operations, sales and marketing data and then planning customized workshop events that are tailored to meet your specific business needs, thereby maximizing your P&L results.• Where's the "Fat" ? Identifying the biggest business potentials to address.• Preparing and delivering Product and Process based results oriented workshops using:- a) DFMA - Design for Manufacture & Assembly - Simplify assembly, reduce part count & component costs. b) VA/VE - Function based brainstorming workshops that deliver Business Cases enhancing functional product value and P&L savings. c) Lean Events - Ensure optimized Takt time for your customers demand and much more. d) Supplier Events - Harness the savings potential your suppliers know about & those not yet mined. e) TRIZ problem solving - For tough specific technical problems that seem unsolvable.

• B&L develops advanced Opthalmic phacoemulsification & adaptive fluidics “Stellaris” surgical handpieces & intraocular lenses, enabling highly controlled cataract & refractive eye surgery.• Principally hired to help compile the EU MDR VOI Risk Trace Matrix. • Tasked to find Design Verification & Validation (V&V) Test Plans, Test Protocols & Test Reports for approximately 1,000 trace mitigation requirements, emanating from the Surgical System(s) risk control documents, DFMEA, HBRA & URRA respectively.• Performed Cataract Lens Removal Eye Surgery upon a porcine eye, as part of the B&L Stellaris Elite Anterior surgical risk training.• Entered 970 Stellaris Labeling Technical Specification Requirement elements into ARAS s/ware to enable full IOVV tracing for the 202X project to support ISO20417 & ISO15223• At the request of B&L regulatory dept. prepared a cohesive EXCEL document, demonstrating all the Verification & Validation Reports executed at each iterative QCR design change step for the Anterior Module Technical Specification.• Traced 433 Cybersecurity Control items to their Product Reference Specs. to identify the Software Test Protocol Elements necessary to execute (SWIT or SST tests) & their documented Design V&V report(s).• Traced gaps and updates to complete the open Useability Requirements for IEC 62366-1 given the URRA, UOUP & PSUR inputs.

• Marizyme produces “DuraGraft”, a patented one-time intraoperative liquid vascular graft treatment, for use in vascular & CABG heart bypass surgeries, that maintains extended endothelial function & structure, thereby improving clinical outcomes.• Hired to review, index & prepare a complete digital scanned PDF version of the historical paper “Somahlution” DuraGraft DHF for formal adoption by the new legal company entity, “Marizyme”, for FDA 510(k) regulatory filing, whilst assuring DHF audit robustness.• Performed gross gap assessment against company DHF procedural requirements, assuring compliance with 21CFR820, ISO13485 & ISO14971.• Created a 45 page DHF Index & closed out the DHF adoption by creating a detailed “Memo to File” listing the DCR changes.

• Hired as a specialist Titanium 3D Additive Manufacturing expert to assist sourcing, evaluating, developing & qualifying a second source of supply for Titanium Spinal Implants.• Identified a list of sixteen OEM 3D “Titanium” Additive Printing Equipment Manufacturers, identifying the top two qualified machine manufacturers of “Powder Bed Fusion” equipment.• Visited two leading tier #1 contract manufacturers to evaluate their vertically integrated manufacturing capabilities & wrote detailed visit reports, documenting their pros and cons.• Assessed the benefits of Hot Isostatic Pressing, versus Vacuum Stress Relief per ASTM F3001 Class A versus Class C & Nano surface descaling technology.• Proposed a way forward to produce representative series production samples for an “A” to “B” performance comparison against the existing production source

• Principally hired to review multiple Environmental & Chemical EU MDR, US FDA, US & EU Pharmaceutical and ISO Standards, to assure NPI launch compliance, for a combination Enteral Fusion Pump, being sold to a major pharmaceutical OEM, for distribution in multiple global markets, to treat Parkinson’s disease.• Lead responsibility for researching & understanding the applicability and exclusion rules, as they apply, to the Infusion Pump and “Fluid Contact” component(s) of the combination device respectively, for the following rules:• Compliance elements: US Prop 65; US Dodd-Frank Act; REACH; RoHS; Endocrine Disruptors; CMR’s; Battery Directive; WEEE• Allergens & Infection Agents: Latex Free; BSE Free• Pharmacopoeia Standards: USP661; USP381; PH.EUR 3.1 & 3.2• Biocompatibility: ISO10993-1• Cytotoxicity: ISO10993-5• Sensitization & Irritation: ISO10993-10. • Irritation “In Vitro” testing alternative options to “In-Vivo” per ISO10993-23 (2021)• Leachables & Extractables: ISO10993-17/18 and USP1663/4 • Tasked with defining supplier letters to acquire the necessary declarations of Conformance and Certificates of Analysis; identifying any Pass/Fail definitive product testing required.• Established an EXCEL matrix to track project progress by P/N.• Jointly responsible for reporting progress to the purchasing Pharma OEM and completing the “JAMA” risk database.

• Reporting to the SQE Manager, responsible for providing an independent review of all design drawing specifications for an Endoscopic Vein Harvesting (EVH) Tool product update.• Reviewing Product Design FMEA & Process FMEA to ensure high risk ranked items had drawing CTQ features controlled appropriately, with specified Pass/Fail criteria that were both quantifiable & measurable.• Working with key suppliers to assure DFM/DFQ feedback taken into consideration and general drawing best practice principles were applied to the designs prototyped, ahead of NPI launch.• Responsible for effecting design changes using Windchill to secure cross-functional team approval.• Led an initiative to improve the way colour branded EVH components were called out on drawings, to assure consistent worldwide color branding, using Minolta colorimeters.

• Reporting to the Sr. Quality Manager, responsible for delivering IQ/OQ/PQ to validate an increase in global US capacity for a new DePuy spinal 3D printed titanium implant acquisition, EIT “Emerging Implant Technologies”• Principally responsible for managing risk, timing and technical delivery of the 3D additive printed Product Verification Protocol (PVE) plan & final report, for a family of “mesh lattice” style Interbody Fusion Spinal Implants: Cervical (CIF) & Lumbar (PLIF, ALIF, TLIF & LLIF).• Material employed was Titanium Ti6Al4V Eli (Grade23) powder per ASTM F3001, using 3D Systems ProX 320 DMP Printers.• Reporting Progress to Senior Management.• Successfully building cross-functional working relationships across international teams & cultures, in a high-pressure project environment.• Developed project tools so the team could monitor delivery of the Static and Dynamic Mechanical Test Reports executed by third party test houses according to ASTM 2077 and ASTM 2267.• Tracked all project Mechanical R&D Test results/progress & helped DePuy R&D Engineering write Quality Acceptance Rationales where 3D Printed sample expertise was required.• Ensured the 3D Additive manufacturer documented their deviations clearly with an appropriately structured risk-based rationale, free from unacceptable risk.• Responsible for proposing all PVE project recovery actions and for managing supplier OQ & PQ deviations, ensuring the final approved PVE report logged into ADAPTIV, as part of the DHF.

• Supplier Controls Workstream, Incoming Inspection Remediation.• Leading a team of 3 Engineers write Incoming Inspection Requirements documents, for complex electronic sub-assemblies, fabricated sheet metal parts and injection molded components.• Conducted DFM/DFQ design review with supplier on-site to pre-assess potential measurement non-conformances that could be identified and addressed prior to FAI, through EC change.• Wrote multiple CoA & CoC requirement forms for various product lines.• Helped negotiate and secure end of line CoA test reporting requirements, for a Chinese & Dutch supplier of complex Patient Monitoring PCB sub-assemblies.• Used Philips eDMR, DMS, SAP and SharePoint systems to research product specifications, quality non-conformance history, complaints & check CAPA history.

• Hired to manage the NPI PVE (PPAP) launch of the “Attune” range of orthopedic knee surgical instruments, employing APQP principles and DFM / DFQ design reviews, as needed.• Accountable for PVE launch of 40 instruments at two key suppliers, making up approximately 100 components.• Coached the suppliers to complete the full suite of required PPAP documentation: Process Layout & Flow Plan; Process Control Plan; Contact Materials List; Material Certs; PFMEA; CTQ Drawings & Capability Studies; Gage R&R ; MSA; TMV & FAI.• Conducted the customer DePuy FAI sample measurement confirmations on-site, using the suppliers metrology equipment.• Organized a comprehensive onsite IQ/OQ/PQ Validation for a Black Oxide chemical processing company, over three separate visits, explaining FDA Validation principles and then principally writing the protocols, designing the OQ & PQ sample runs, executing & writing the final Validation OQ & PQ reports.

Zimmer Biomet – Project Trident (Production & Sourcing Controls)Responsible for completing Special Process Validation & Remediation in compliance with FDA 21 CFR Part 820 Quality System Regulation within an ISO13485 & ISO14971 medical device manufacturing and risk management environment.Significant exposure working with team members performing:➢ CAPA➢ Test Method Validation (TMV)➢ Software ValidationTasked with reviewing, creating, executing and remediating supplier IQ/OQ/PQ reports, as necessary, against Zimmer checklist F-43.416.1B and writing concluding Memos to File.Completed various Special Process Validations including:➢ Gamma Sterilization➢ Electron & Laser Beam Welding (Semi-Automatic➢ Injection Molding➢ Heat-Treatment➢ Electro-Polishing➢ PassivationZimmer Biomet - Integration Team (SPPA Business Transfers)Tasked with leading the ZB Supplier Production Process Approval process (SPPA) for multiple Trauma transfer projects, bringing world class Advanced Product Quality Planning (APQP) experience to the team.Delivered support & guidance to the ZB supply base to deliver compliant documentation and effect SPPA transfer:➢ Material Contact Lists➢ Animal Derivatives Survey➢ Process Flow Diagrams➢ Control Plans➢ Product Inspection Plans➢ Measurement Systems Analysis➢ TMV➢ Gauge R&R Studies➢ Capability Studies➢ PFMEA’s➢ Special Process Validations➢ First Article Layouts➢ SPPA product warrant

Responsible for implementing a Value Culture, targeted with saving 2% of sales/year. Reported to Director Commercial Diesel Finance & Analysis.➢ Developed strategy for generating and delivering VA/VE savings. Presented and sold process to Global Supply Chain and Plant Executive teams in USA, Germany, UK and China. Used global in-house website to track projects.➢ Performed in-depth supplier-quote reviews against “should cost” targets to identify leveraging & lean manufacturing “win-win” opportunities worth > $2 MM.➢ Accelerated savings by researching competitive quote information and providing cost gaps to the Commodity Manager for commercial cost leveraging.➢ Planned currency risk sharing agreements, halving exposure to currency risk.➢ Introduced commodity map and 3-day “SAVE” Waste Gate workshop for 20 cross functional product experts to systematically identify savings opportunities, drilling down below the surface, resulting in over 100 ideas saving over $6 MM.➢ Mentored three plant cost reduction teams to embrace VA/VE idea generation techniques. Coached, aided and supported idea implementation.➢ Re-quoted Waste Gate business using alternate manufacturing processes to establish cost gaps, identifying $5 MM in savings opportunity.➢ Performed SAP system data mining, to scope the most valuable commodities and suppliers spends, prioritising effort and isolating areas to attack.

One of a team of five Engineers tasked with delivering $5 MM annual savings.➢ Project Lead for the Boeing 737 Auxiliary Power Unit (APU) Start system controls packaging: Start Power Unit (SPU) and Start Control Unit (SCU) pressure die-casting project. Savings $1750 per SCU and $785 per SPU chassis worth $0.5 MM/year over 200 aircraft. ➢ Led VA/VE project to convert Airbus A380 SPDB Heat Exchanger back-plates from machining to die-cast.➢ Led Die-Cast chassis re-design project for Boeing Fuel Tank Nitrogen Generation System (NGS), Bite Display Unit (BDU) used upon 737, 747, 757, 767 and 777 Aircraft.➢ Managed technical design, project budget planning and control, using earned value methodology to keep spend and timing within +/- 5% of plan.➢ Guided the FEA analysis effort ensuring appropriate safety margins with respect to minimum FAA and Boeing Source Control Drawing (SCD) requirements. Established casting factor and load factor of safety with appropriate Non-Destructive Test (NDT) controls per ASTM 2175.

Management Tracking and Control:➢ Developed over 150 business cases, timelines and action plans for capital approval, saving between $2 MM to $4 MM annually, worth 2.2% to 3.6% of sales revenue 2003/8. Highest performing VA/VE team globally.Capital Projects:➢ Specified and installed $2.75 MM Electro-coat paint and wastewater treatment system. Resulting in 50% savings plus reduced WIP and freight costs. Projected ~$35 MM lifetime savings at $1.75 MM/year.Technical Sales:➢ Re-packaged Bosch Hydro-Boost with a Vacuum Pump & Booster for Ford P356 (SRW) Diesel Truck platform, generating $50.70 savings/vehicle worth $6.1 MM/year to Ford adding $5.9 MM incremental sales for TRW & displacing $14.4 MM Bosch sales.Operations Savings:➢ Uncovered excessive grease use and over charging $1MM /yr➢ Identified packaging savings by replacing disposable dunnage with returnables. Wrote Excel model to determine returnable loop size and estimate dunnage life expectancy for Booster Shells. Saving $100K/yr.➢ Evaluated Freight Data to identify consolidation, scheduling and routing opportunities. Tracked $ cost per pound per mile. Ran trucks near full capacity. Savings >20%➢ Obtained fair market value for Scrap Steel Borings and Aluminum chips. Saving $2 MM/yrProgram Management:➢ Managed projects from concept through SOP using APQP and GDPIM gates.➢ Supported multiple PPAPs and prepared OEM change approval presentations.Engineered Design Savings: ➢ Re-designed 2-piece steel welded bracket into double flared tube without weld. Savings $0.77/ea., worth $230k/yr.➢ Sourced Korean LCE stamping tooling, reducing capital tooling by 30%.➢ Redesigned M/cyl Pistons to fixed seal type, enabling massive material and processing savings. Replaced bar-stock with near net shaped cold forged blanks. Saving $0.75ea on 6 million pistons $4 MM/yr.➢ Performed Booster & M/cyl benchmarking to identify cost, performance and design targets. Revealing E-coat-paint and tie-bar savings.

● Developed Advanced Automotive Actuation Braking Systems for Chrysler JEEP KJ & Dodge RAM DR truck platforms within a QS9000 quality environment. ● Applying in depth knowledge of various manufacturing processes, APQP, FMEA, DFM, DFA, DFQ, SPC, Tol Layouts and GD&T.● Designed, Managed and Released reliability assured Vacuum Booster and Master Cylinder Duplexes through CV, DV & PV phases into volume production whilst meeting stringent BOM cost & vehicle system performance targets.

● Managed Engineering Design, Development and Release responsibility for the Mazda AAI account (Mazda 626 & Ford Probe - Buckles & Retractors).● Mentored in Japanese continuous improvement culture & philosophy by experienced local Japanese co-ordinators (ie.Kaizen, 5S, Kamban, Quality Circles, JIT, TQ, Taguchi DOE)● Visited TRW Alfdorf to investigate & prepare for N.American localisation of RT-1 buckle manufacturing & design technology.

● Designed, prototyped & released a World class Truck Spring Brake Parking Actuator following a QFD house of quality exercise to derive the design specification requirements.● Received a European Patent for a novel cable quick release mechanism for a Spring Brake Actuator enabling brake release and simple reset.● Certified ISO9000 Auditor.● Designed and released Bendix AL-2 ABS ECU housing, RFI shielded with integrated heat sink, meeting DIN 40050 IP65 sealing, ingress & impact requirements.

● Principally responsible for the design, development & production support on the Land-Rover, Jaguar and SAAB range of Vacuum Boosters, Mcyl's and Suspension Levelling System.● Completed a comprehensive Engineering Procedures Manual for ISO9000 accreditation purposes.● Re-designed a servo diaphragm seal, that had caused Lucas in excess of £1m warranty claims.● Completed comprehensive Lucas Open Learning certified training courses.

● Responsible for all bought out components and factory consumables, order placement, price negotiation, vendor scheduling, goods inwards inspection and inventory management.● Grounding in commercial buying and inventory management.● Learnt how the the various departments within a small business function and relate.