Mark Roy Email and Phone Number
I have just started the next phase of my career at Merz Aesthetics as the Medical Device Supply Chain Manager.I have been an electrical engineering professional with a passion to work on modern technology as a verification and validation test specialist, design and design transfer engineer. As an individual contributor, I have been hands-on and close to the technology in a lab to develop RF, Ethernet and signal harness products as part of a Systems Integration team while maintaining design for manufacturing and service per regulatory standards. I have been very fortunate to work on the electronics of Military Electro-Optical, RF Payload in Satellites, Cell Phone Base Stations and Medical Devices in my career. Now I will be managing in the Service and Repair side of the business for Ultrasound equipment used in the Health and Wellness industry.My philosophy is continuous improvement where I apply what I have learned while utilizing wing-to-wing analysis. I have a passion for assuring defect-free documentations for designs and deliverables for my internal and external customers. I am always happy to collaborate with the team, provide training and build people.
Merz Aesthetics
View- Website:
- merzusa.com
- Employees:
- 2849
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Merz AestheticsWaukesha, Wi, Us -
Medical Device Supply Chain ManagerMerz Aesthetics Jun 2022 - PresentRaleigh, Nc, UsOn behalf of Service, working on standardizing Service Center repair process, reviewing and developing service documentation, including leading process validations, provide direction and leadership to Global Service Centers and resolve service center operational challenges by proactively managing materials and repair cycle times. -
Service EngineerGe Healthcare Jan 2015 - Jun 2021Chicago, UsService Engineer Expert on Global Service Operations Team where I have compiled and cataloged Service Tool and Field Replaceable Parts from multiple data and documentation sources onto a single Global catalog (400K items). Over a 2.5 year time span, I have leveraged 30+ engineers and regulatory experts to assess which of the item listings are obsolete technology (eliminated 250K items resulting in $1M Service Productivity) while in parallel, directing QA/RA to make Medical Device determinations for 150K service replacement items (Resulting in no FDA findings in recent audits). As a Senior Analyst, I have applied data filtering techniques for 2M+ complaint records (over a 2 year period) to assess where highly regulated UDI identifiers were not found in FDA regulated customer complaint records. I have also created product surveillance reports for R&D engineers for use to apply new designs for product improvements. I have led projects and conducted wing-to-wing root cause analysis for identifying the missing UDI data gaps. Once the root causes were understood, I have prepared and influenced business leaders with project proposals to lower risk of FDA findings with improved processes and data flow. This resulting in the North America Region KPI for UDI capture from 70% successful UDI capture in complaint records to 93% among 500K complaints. As the service engineer expert, I have also worked on a Global service tool set up process, implemented it globally and provided training to engineers from all regions. This effort resulted in reducing new tool set up time by 50% while avoiding duplicate tool set ups. This effort also gives the assurance that all necessary service instructions and required verification and validation of new tools are in place before having them available for orders. -
Lead Service IntegratorGe Healthcare Nov 2011 - Mar 2014Chicago, UsAdvocate on behalf of Service on both NPI and sustaining product teams. I reviewed new service features that were conceived by R&D and defended the service features for maximum benefit for the field service engineer and customer while remaining in alignment with NPI budget, FDA regulation and Quality processes. This included performing wing-to-wing analysis from manufacturing to service to best assure supply chain and service part distribution. My routine roles and responsibilities included preparing the V&V planning, creation of procedures, conducting V&V tests and reviewing the results for Service Methods, Field Modification Instructions, Service Notes, new Service Tool Kits and cataloging the completed documentation in the Design History Folder. My efforts and leadership resulted in over 90% on time part fulfillment at the lowest Installation and Warranty costs. I have applied DFS (Design for Service) principles with service method development, tool kit design and validation testing. -
Lead Program IntegratorGe Healthcare Jan 2007 - Nov 2011Chicago, UsLead Program Integrator in the Global Parts Organization for Service Replacement Parts distribution. In the MRI Modality of GE Healthcare, I have aligned with Engineering to derive service spare part strategies to support new and sustaining programs . I have also performed a service review of sustaining products to find opportunities to address end-of-life service parts with backwards compatible NPI parts on a NPI program. This included reviewing verification and validation documentation for FDA compliance. I have also influenced the Sourcing teams to drive suppliers for the lowest cost and delivery times to 60+ global warehouses and 100% on time stocking for product launch. -
Manufacturing Project EngineerGe Healthcare Aug 2004 - Jan 2007Chicago, UsEngineering Supplier Transfer Project Leader on behalf of GE Healthcare Manufacturing. I have led over 25 projects to achieve higher quality purchased parts with lower cost (savings $2M), higher quality (improved FPY by 40%) and improved on-time delivery fulfillment by 30%. The projects included assessing new suppliers, obtaining prototypes, negotiating lower costs and performing verification and validation with supplier and GE Healthcare Manufacturing. I have also traveled to several suppliers in US and India to review supplier manufacturing, worked with Sourcing to obtain quotations and set up blanket purchase orders at GE Healthcare. I have prepared documentation and achieved cross functional team approvals to validated new supplier fulfillment performance. I have applied Six-Sigma quality data analysis techniques to assess component quality trends. I have also participated in several Kanban workouts to submit efficiency concepts and implement them for the Manufacturing assembly line. Provided pitch to business leadership weekly with project updates. With 3 straight years receiving perfect annual review rating, I was selected by senior management to attend GE Corporate leadership training in Crotonville, NY. -
Senior Manufacturing EngineerOmega Engineering May 2002 - Aug 2004Norwalk, Ct, UsContractor at GE Healthcare as Senior Manufacturing Design Transfer Engineer. NPI Team member and Manufacturing advocate. Acted as liaison between Product Engineering and Manufacturing to interpret designs, prepare manufacturing methods and establish assembly lines for MRI products. Owned supplier surveillance and monitored supplier quality by performing First Article Inspections of purchased parts and documented results per GE Healthcare Quality process. Processed several Blanket Purchase Order set ups on behalf of Manufacturing in Oracle system. -
Senior Electrical Design EngineerMarconi Jan 1996 - Jul 2001Dallas, Texas, UsElectrical Design Engineer on telephony infrastructure equipment used by cell phone providers. Assessed customer needs, developed equipment list and designed necessary cabling to complete a cell phone tower electronics cabinet. Traveled to customer headquarters (Sprint, Nortel and AT&T) to review electronics configurations which included power rectifiers, security alarms, temperature cooling and heating, high current batter back-up strings, EMC shielding, RF interfaces to customer tower radios, antennas and accessories. Design concepts supported manufacturing, service and installation. Designed all cable harnesses and worked directly with supplier to drive quality up and costs down. Supported cell site technicians and performed service calls around the USA. -
Rf Test Consultant - System Integrator And Pay Load TestSpar Aerospace Limited Dec 1992 - Sep 1995Spacecraft RF Test Consultant and System Integrator for the USA/Canada owned MSAT Satellite program. Reported to RF Engineering to obtain test parameters before each shift and then lead technicians to carry out the complex RF test measurements on components followed by integrating these components onto spacecraft payload and analyzing data from earliest assembly to final assembly for spacecraft launch. Coordinated with manufacturing team to perform testing and communicated phase lengths of 10 Ghz RF transmission line to meet tight RF phase requirements. Skilled in RF Power, Insertion Loss, Return Loss, Signal-to-Noise, Antenna Gain, Impedance Matching, EMI/EMC testing and other measurements. I have reviewed RF data and recommended mechanical/electrical corrections. Tuned filters and wave guides to minimize return losses. -
Test EngineerHughes Aircraft Company Jul 1981 - Nov 1992Philadelphia, Pennsylvania, UsTest Engineer responsible for US Navy Military electro-optical assemblies used for FLIR and targeting system on Grumman A-6E Intruder aircraft. Created, validated and released several test procedures per military CORE standards. Supported test line and troubleshot electronics and laser optics at component and assembly levels. I was a systems engineering technical writer and also RF tester on Hughes Satellite payloads.
Mark Roy Skills
Mark Roy Education Details
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Devry UniversityElectrical And Electronics Engineering
Frequently Asked Questions about Mark Roy
What company does Mark Roy work for?
Mark Roy works for Merz Aesthetics
What is Mark Roy's role at the current company?
Mark Roy's current role is Developer of Product Service Strategy | Design Transfer Specialist for Service | Device Failure Data Analysis | Verification and Validation | Medical Device Products.
What schools did Mark Roy attend?
Mark Roy attended Devry University.
What skills is Mark Roy known for?
Mark Roy has skills like Leadership, Presentation Skills, Design For Service, Medical Device Fda Regulations, Health, Microsoft Powerpoint, Hospitals, Environment, Field Engineer Procedures, Medical Devices, Technical Writing, Safety.
Who are Mark Roy's colleagues?
Mark Roy's colleagues are Deborah Hsu, Andressa Nascimento, Thais Lacerda, Alla Lasskaya, Nicholas Thayer, Hyungeun Jang, Wendy Bernard.
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