Transition micro-fulfillment system components to full production.

BD PHOENIX AP SAMPLE PREPARATION SYSTEM: System contains an Input conveyor, output conveyor, mixing / nephylometry station, XYZ robot and Z-theta robot. The early design choice to use a welded base for this unit resulted in many tolerance problems and required extensive work with our sheet metal vendor to identify critical areas and to resolve dimensional issues either through improved manufacturing techniques, assembly tooling or though redesign. Resolved numerous problems with system alignment and fit and finish of covers. The 300th production unit was recently shipped SUGIQUEST AIRSEAL DYNAMIC PRESSURE SYSTEM: Participated in early product development of this device. Contributed much DFx and conducted the first pilot build. Built a mock up to establish wire routing and harness design. Having the wiring Harness defined early greatly speeded up the initial build. Major design changes were rolled in during the pilot to production phase to address excessive sound output. Trained assemblers and technicians on assembly techniques and developed tooling such as, leak test sets, tube forming tools, venturi installation tool. Pilot build and two production builds were completed at KMC. http://www.surgiquest.com/ifs.html#prettyPhotoLabNow CD4NOW BIOCHIP ANALYZER: Had extensive involvement during development of this analyzer. Through examination of the Solidworks model throughout the early design I was able to make many DFx suggestions. Significantly reduced fastener count and improved assembly flow. Assembly paradigm went from ‘build it in a box’ to ‘build the whole module and then put it into the box’. This greatly improved the assembly process and allowed easy access to components during assembly. Product never went to market.

NEWTON: Mass spectrometry Time-Of-Flight system. System identifies 1000+ bacteria, fungi and molds. Utilizes high vacuum system, high voltage electro-optics and UV LASER. Many subassemblies are built under HEPA flow hoods. Responsible fro work instruction and Bill of Material. Built BETA and Pilot instruments and currently preparing for full production. BLOODHOUND INTEGRATED HEMATOLOGY SYSTEM The Bloodhound™ System uniquely combines a digital image-based cell locator, cell classifier and cell counter with its own slide maker and stainer. System contains 32+ stepper motors, 90+ sensors, extensive fluidics handling system and pneumatics. Worked closely with design Engineering during Beta development. Worked with Design to establish Model structure (for reuse in work instructions) and Bill-of-Material structure. Responsible for coordinating the Building of Prototype, Pilot and Clinical machines. Directed technicians and assemblers. Utilized 3D Solidworks Composer work instructions. Reduced production build times by 30% using LEAN tools. BIO-FLASH CHEMILUMINESCENCE ANALYZER: This complex system has multiple syringe pumps, sample and cuvette carousels, a cooling chamber for reagents and an incubation chamber. Sensing technology is magnetic particle based using a Luminometer for analysis of samples. Participated in pilot builds and transfer to production. Worked with assemblers and Engineering to to create logical modules, greatly improve assembly and to improve wiring and plumbing layout. GE SPINLAB AUTOMATED MULTICHANNEL HYPERPOLARIZER: KMC SYSTEMS is responsible for packaging the Hyperpolarizer module and providing conditioning and handling of samples. Built mockup of system to allow team to better assess and improve system layout. Provided input for Bill-of-Material structure. Created 3D work instructions for several complex subassemblies during prototype build.

OVID: Treatment system for hypercholesterolemia. System utilizes pinch valves, pump and scales to process Plasma in a disposable. Restructured Engineering Bill of Material to improve manufacturing process. Led Pilot build for FDA submission.ROZ: 22 axis robotic medical sample handler. Participating in early development efforts. Set up production area, coordinated parts rework as needed for prototype build. CELL HARVESTER: Bench top stem cell processor. Unit consists of 9 integrated electromechanical modules. Created Solidworks Composer Work Instructions for Pilot and Production builds. QUATRO: 32 channel real time PCR. Resolved difficult assembly sequence by modeling alternate methods and deciding on best method. Created final Work Instructions for Pilot and Production builds.IRONMAN: Very stable bench top imaging systems for imaging of Multiple well microplates. System has optical components including camera, collimator, beam splitter, XY galvo’s and brightfield illuminator. Managed bill of material and worked with manufacturing personel during first production build. Designed assembly tools as needed. Directed methods specialist to create work instructions.

MANUFACTURING / DEVELOPMENT ENGINEER: Directed technicians during development builds and interfaced extensively with Engineering design disciplines. Worked with Mechanical, Electrical, Software, Quality, Systems and Controls Engineers. IBOT 4000 MOBILITY SYSTEM: This is a class 3 medical device. It climbs stairs, curbs and dynamically balances. System is ‘fail functional’ utilizing triple redundancy where required. Had responsibility for building third generation development devices used for engineering verification and qualification. Completed detailed visual process documentation for mechanical assembly, electronics assembly, and user interface. Gained experience with environmental, EMI, EMC, IPX (Water ingress), and durability testing. Spent much time in Detroit working with electromechanical assembly houses during transition to manufacturing. Provided liaison between the manufacturers and DEKA to solve design-for-manufacturability and assembly problems. EXTRA CORPOREAL BLOOD TREATMENT SYSTEM: This system pumps a patient’s blood out of a leg vein, performs some chemistry while maintaining blood temperature and pressure, and returns the treated blood back to the patient. Unit is a file cabinet sized console and contains pneumatics, pressure sensing, and temperature sensing subsystems. Had overall responsibility for developing assembly flow and assembly techniques. Created detailed visual assembly documentation in anticipation of future manufacturing. This device went from concept to clinical units in 18 months. OTHER MEDICAL DEVICE EXPERIENCE: Provided Manufacturing Engineering support for two Human wearable devices (insulin pump, gastric bypass) and an Emergency room diagnostic device (Breathquant). Coordinated builds, provided test equipment and generated documentation.

MKS INSTRUMENTS is an 800mil company that builds instrumentation and sensors used in the manufacture of semiconductors. MKS is a high mix - low volume production environment. DAILY PRODUCTION SUPPORT: Debug machine, process and part problems in a fast paced, LEAN manufacturing environment. Gained knowledge of cleanliness issues unique to semiconductor equipment and processing. LEAN MANUFACTURING: Work with teams implementing Lean Manufacturing and 5S production system. PROCESSES: Develop processes for welding and assembly. Processes are primarily visual based and accommodate various language comprehension levels. Processes ranged from simple mechanical assemblies to more complex instrument calibrations. GAS TUNGSTEN ARC WELDING: Developed programs and weld schedules for semiautomatic welding of Inconel and Stainless Steel tubing. Used Weldlogic and MK Products power supplies with standard torches and Orbital welding heads. Developed programs using straight torches and orbital welding heads. VACUUM: Rewrote and implemented vacuum leak testing standard. Developed process controls and process audits to maintain quality of process. This task required a thorough understanding of all parameters pertinent to leak rates in the 1.0E-09 scc/sec He range.QUALITY METRICS: Summarized quality metrics using Access, Excel and NWA for three production groups. Used software to mine database and to present data using Pareto charts and control charts.LASER MARKING: Responsible for the installation, test and process documentation for six 90W LASER markers. Developed laser programs for marking Data-Matrix bar-codes on sensors.

SPECIAL PROCESS EXPERT: Recognized by company and customers (customers include Pratt & Whitney, General Electric, Rolls Royce, FAA….) as the in-house technical expert in several special processes including Vacuum heat treating, Atmosphere Brazing, GTAW (TIG) Welding and Resistance Welding. Developed procedures, checklists, training and certification requirements for these processes. Certified processes and operators to various specifications including MIL-STD-1595, MIL-W-6858, AMS-2750, AMS-2769, and General Electric Aircraft P10TF1 among others. The methodologies utilized for the development of these processes can be applied to many other critical processes.AIRMAN REPAIRMAN: Held FAA license to certify repair of instruments. SENSOR PROCESSING REQUIREMENTS: Familiar with the unique processing requirements of sensors including: thermal stabilization treatments, stabilization cycling, iterative calibration cycles, and thermal drift characterization.Overall responsibility for the manufacture of a variety of electromechanical aircraft sensors including Pressure Transducers, Fuel Quantity Sensors, Oil Quantity Sensors, Fuel Flow Sensors and Fire Detection Cables. Meggitt is a job shop company, producing multiple short run unique products simultaneously. ASSEMBLY AND PROCESS EQUIPMENT EXPERIENCE: Provide daily solutions to manufacturing departments utilizing the following assembly and process equipment: Environmental chambers, high pressure air compressors, vacuum heat treating oven, belt furnace brazing oven, resistance welders, induction brazers, TIG welders, soldering equipment, electrical and pneumatic test equipment among others. Provide solutions to problems with the above equipment and coordinate repair as necessary.