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Product Development: Product Development Process (GATED), CAD, GD&T Validation (IOQ, PQ, Engr. Study) Contract Manufacturing, OEMContinuous Engineering: Continuous Improvement, VA/VE Lean Manufacturing (JIT) Automation, Value Stream Mapping Cross-Functional Teamwork Project / Program ManagementStaff Leadership: Staff Coaching & Mentoring Hiring, Training & DevelopingManager with 24+ years of Product Design & Development, Manufacturing experience, Product Support and a reputation as an influential change agent with cGMP expertise, for Biomedical, Life Sciences, Biotech, Forensics & Toxicology, Drug Discovery, Consumer Products and Pharmaceutical Industries.Extensive Experience with Product/Instrumentation Platform Design/ Development/Validation/Launch, Systems Integration, Quality Systems (KPI), Production / Automation, Disposables, Project Management, Process Flow / Optimization, Automation, and Business / Applications Development
Successful Product & Platform launches with Disposables following Gated Product Development Process (URS, Requirements, VOA, CAD with GD&T, Rapid Prototyping, Validation, Life Cycle Testing Reliability, Process Control & Monitoring).Recognized for leveraging strong work ethic and interpersonal skills to lead cross-functional technical teams.
Applications:
SolidWorks, LabView, MiniTab, AutoCAD, ANSYS, CETOL for Tolerance Analysis, MS Office, MS Visio, MS Project, Adobe Photoshop, FLOWORKS. ALGOR, Howard Graphics, Sigma Plot, PDM, Power BI.Newell Corporation, IL 06/2020 Present
Manager SME, Value Engineering, Continuous Improvement, Lean Chicago, ILNewell Brands Inc. is an American manufacturer, marketer and distributor of consumer and commercial products.
Implementation of Value Added / Value Engineering (VAVE) projects across various portfolios such as Beverage, Coolers, Grills, E-lighting, Tents, Shelters, Furniture for the Outdoor & Recreation Business Unit.
VAVE Projects follows gated NPD Stage Gates, with deliverables and cross-functional reviews, with alignment with NPD, Brand, Marketing, Sales, Quality, Sourcing, and Regulatory.
Projects include detailed project timeline with key deliverables, validation including FAI, PP Checklist, PPAP, Risk Management, TR Reviews with stakeholders, risk mitigation, ECNs, BOM & drawing updates. Average project completion time is 4 5 months with an annual savings of $ 100 K - $ 750 K. Incorporation of alternate resins like Ecozen, Zylar instead of Tritan for molded beverage products. Alternate SS material like SS 201 instead of SS 304 for thermal beverage products providing in excess of 25 % savings. Optimization of manufacturing process for Cooler bodies and lids (SKU Optimization, Cycle Time Study) to improve the utilization to more than 95 %, with reduced product handling. Incorporation of Calcium Carbonate to the mix for injection molding provided improved gross margins and better adhesion to the Poly Urethane for Cooler manufacturing operations. The Annual VAVE savings improved from $ 650 K in 2019 to over $ 3.75 M in 2024. Packaging / Process improvement Initiatives. Optimization of the 4 / 6 pack outer packaging for sourced beverage category products to improve container utilization by more than 20 %, along with implementation of slip pad packaging to significantly improve loading and offloading times (75 % savings).
Elimination of shrink wrap and PVC packaging to paper molded packaging options. Automation / Lean Projects. Actively involved in automation / fixture (tooling) projects at the Cooler Factory in Wichita, that improved the working ergonomics, overall productivity and the quality with installation of Case Packers.
Automated Handling of the Injection Molded 70 qt coolers using gantry robots to grab and place them on conveyors improved productivity by more than 25 %. Use of Fanuc Robots for the install of the side handles and hinges for the 70 qt coolers with Keyence sensor verification reduced 1 FTE and lean annual savings of more than $ 650 K. Working on introduction of Autonomous Vehicles for effective management of WIPS (Cooler Body / Lids). Also worked with sourced vendors to incorporate tooling / fixturing and post operation verification.Luminex Corporation, IL 02/2019 06/2020
Manager Engineering, Automation, Design Transfer North Brook, ILLuminex is a subsidiary of Diasorin involved in laboratory diagnostic equipment for molecular diagnostic assays.
Implementation of the cGMP compliant Automated High Speed Lines (350 Part per Hour) for the Disposable Diagnostic Cartridges for the Verigene I / II diagnostic equipment platforms.
High Speed Lines for the Cartridges incorporating SCARA Robots involved parts pickup, Assembly, Verification, Liquid Filling, Heat Staking with Inspection, Label Printing with Inspection. Automated system includes Laser Marking with Verification followed with Leak Testing ( Hybridization Chip ). Initial design / layout, capex approval, contract manufacturing, installation / validation (FAT, SAT, IQ/OQ/PQ followed the staged gated process development with deliverables and reviews.
Project included the integrated automated system includes Laser Marking with Verification followed with Leak Testing ( Hybridization Chip ) that improved the yield by more than 50 % over the manual stations. Process Improvement / Error proofing helped improve the overall production yield exceed 97 %. Process Improvements for the equipment manufacturing, including creation of Test Fixtures for increased Process Efficiency (PCR), Infrared Temperature Probes for Fixture Thermal Calibration, and vison system for labels.Wockhardt - Morton Grove Pharmaceuticals, IL 01/2016 02/2019
Manager Engineering, Operations, SME Morton Grove, IL Morton Grove Pharmaceuticals makes and distributes prescription and over-the-counter generic liquid drugs. Implementation of FDA mandated cGMP compliant Track & Trace Project involving the Serialization of the Lowest Unit of Saleable Packages, Case Packs with verification.
The Serialization Project was an elaborate capital intensive project, that added new equipment like cartoners, bottle labelers, fillers involving five production lines. The overall scope included the vendor selection, Capex approval, line layout update, equipment ordering, followed with FAT/SAT followed with final IQ/OQ/PQ completion. Project improved the Overall Plant Utilization by more than 40%, and provided a Reduction of Packaging / Labeling SKUs by 30%, and overall labor force Reduction of (20 30 %).
Consolidation of the primary packages for 8 oz / 16 oz / 32 oz bottles and minimizing the head space for the secondary packaging. Reduced the number of carton configurations by more than 30 %. Implementation of new Capital intensive projects ($ 1 - $ 3 M annually) included the RO System Upgrade, Process Equipment, Integrated Fluid Delivery Systems CF / PD Pumps, Blenders. Implementation of Vision System to detect Internal Defects, Low Fill Volumes Detection. Implementation of Vision System to detect Internal Defects, Low Fill Volumes, and OCR Text for Bottle Labels on the High Speed Production Line (Product with Amber Glass Bottle).
Vision System provided a reduction of overall Processing Time of 1.5 hours (20 %) and reduction of 1.5 Personnel (12 %) and 100 % Overall Inspection.
Implementation of the Next-Gen CFR-11compliant, Blue Mountain Regulatory Asset Manager for Calibration, Maintenance and Asset Management System at Morton Grove Pharmaceuticals.
Videojet, Inc. (Danaher), IL 02/2014 01/2016Program Manager Technical Lead / SME NPD, VAVE Wood Dale, IL Videojet Inc. is the manufacturer of coding, marking, and printing equipment including the Ink Jet Printers. VAVE Capital projects ($ 2 - $ 3.5M annually) including development of project scope / user requirement documents, ROI justification, capital requisition (CAR), gated NPD Stage Gates, with deliverables, validation and cross-functional reviews followed with SOP / drawing / POS updates. Next-Gen CIJ (Ink Jet) Printer OEM Eclipse DC Pumps (Ink / Air) project with prototype evaluation followed with accelerated life testing. The VAVE provided 25 % Gross Margins improvement along with improved the reliability and the MTBF. Implementation of the Low Leak Detection Procedure for screening of incoming Nozzles, that eliminated Out-of-Box failures during customer installs. Conversion of machined plastic components to molded components provided a savings of 40 - 70 % over comparable machined components. Dual Sourcing (Alternate Vendor for North America and EMEA Design and Launch of the Bladder (Injection Mold) & Cartridges (Blow Mold) for the EU and the US Markets for the CIJ Printers. The project included detailed Engineering Drawings, Flow Analysis, GD&T, Assembly Automation, FAI, Life / Accelerated Testing.
IMI Cornelius, IL 01/2011 02/2014Program Manager Technical Lead / SME NPD, Continuous Engineering Glendale Heights, ILIMI Cornelius is the world's leading supplier of beverage dispensing and cooling equipment Implementation of Value Added / Value Engineering (VAVE) projects across Beverage Dispensers, Ice Dispensing Machines, and Frozen Beverage Dispenser (ICEE). The Next-Gen Frozen Dispenser (ICEE) required the redesign of the Mixing / Dispensing Valve. The Integrated Molded Module with a unique 3 Way Valve significantly reduced the number of component, and reduced the Overall Dead Volume for the Fluid Path. The project also included the incorporation of a novel Check Valve. Selection and implementation of a pressure switch with remote sensor and sealed bellow design to address the fatigue failure coupled with low temperature exposure (freezing) observed in the field. SKU reduction of DC motors used for the Ice Machines to improve the COGs. Worked with Bison Motors to conduct End-of-Life testing to improve the MTBF of the motors. Initiated end-of-line testing of motors to significantly reduce out-of-box failures. Next- Gen Automated Beverage Dispensing System (ABS, McDonald) required the Creation of the Requirements Documentation based on the Voice of Customer, Service and Reliability Data, followed with the Risk Management and Sub System Level DFMEA documentation. The new platform development included incorporation of new valves with minimal cross talk, and stepper motors with sensors to detect filling errors, path blockages.
Baxter Healthcare, IL 01/2007 01/2011Senior Principal Engineer Global Infusion Systems Round Lake, ILBaxter Healthcare is a health care, medical device company manufacturing products to treat kidney disease, and other chronic and acute medical conditions. Technical Lead involved in Design Improvements, Systems Integration & Interface Requirements Development & Testing, and Tolerance Analysis (Monte Carlo Simulation) of Next-gen Infusion Pump subassemblies. The projects include detailed project timeline with key deliverables, validation including FAI, PP Checklist, PPAP, TR Reviews with stakeholders, risk mitigation, ECNs, BOM & drawing updates. Design of a novel magnetic flux heating procedure for significant reduction of de-gass , provided relief over conventional pad heating for dialysis. The On-Demand heating technology required elaborate PID control for cases of potential blockage of the tube (kinking) due to patient movement during the peritoneal delivery of the dialysis fluid.
Development of novel concepts (ozone) for disinfection for prolonged usage and rapid heating of the bags for faster cycle times (Dialysis Application). The validation included bio-burden studies simulating Home Dialysis scenarios.Orochem Technologies, IL 05/2001 01/2007Director Engineering, Operations Lombard, ILOrochem Technologies is a Biotech and Chromatography company to manufacture unique Sample Prep Technology Products. Automated Liquid Handling Equipment with Gripper for Drug Discovery, Toxicology, and Forensics Applications. Design and Development of the BIS V Flex Liquid Handling System, and the Bio Spotter containing Stepper Motors, Servo and DC Motors, Slide Mechanisms for the for the Life Science Sample Preparation & Extraction, Toxicology, Forensics, Clinical markets. The project involved Stepper Motors, Linear Actuators, Valves, Vacuum Pump, with the development following Stage Gate Process and CGMP protocols.
Designed and developed a Bio-Spotter for the DNA /RNA expression industries for arrays . The platform development involved Assay / Protocol validation with Pharma and Forensics Labs. Production Support and Scale-up for Kits. Prototype, Fabrication & Integration and Scale-up of Complex Biomechanical Kits, Integrated Microplate reactor Blocks, Shakers, Peltier Technology based Cooling Blocks, Vacuum Manifolds. Design and development (molding Polypropylene) of 1/5/10 ml cartridges/columns, 96 well microplates. Alternate Energy Platform Development. Process Development & Optimization of Fuel Cell H2 Gas with Reli-On included prototype testing followed with
scale-up and integration into commercial power generation unit. The Moving Bed Extraction was designed and developed as a viable source of chemical synthesis and sample purification / cleaning applications
Packard Bioscience Co. (Perkin Elmer), IL 10/1997 05/2001Program Manager (Applications) Automation & Platform Development Downers Grove, ILPerkin Elmer is leading supplier of automated liquid handling, sample preparation tools and advanced biochip technologies. Integrated Platform development for Drug Discovery and Genomics Applications. Design and development of Gripper Arm for the Multi-PROBE II Liquid Handling Instruments, and Integrated OEM Proteomics / MALDI-TOFF and Drug Discovery Automation platforms, which involved seamless integration of external devices like shakers, reactor blocks, PCR modules.
OEM micro-printing platforms for array printing using Piezo Tips for the Genomics, DNA/RNA Screening markets. New Product Design / Development. Development of new 1 l and 10 l disposable tip (polypropylene) compatible with the current 100 l and 1ml tips, enabling accurate and repeatable dispensing of 0.5 l. Design and development of new hardware to allow seamless integration of external devices as part of assay development.Genometrix Inc., TX 09/1993 10/1997Technical Lead Engineering & Operations The Woodlands, TXGenometrix Inc, was involved in the development of molecular imaging system it believes can demonstrate single molecule detection, and low / medium density Arrays . Platform development for CCD Scanner and Micro Array Printer development. Design and development of the cGMP compliant DNA-based molecular imaging instruments, including the CCD "bio-scanner" with PC based instrumentation on-line quantitative data analysis, along with the micro-printing platform for the creation of arrays / biochips using DNA/RNA/Peptides and 20-mer oligos.
Commercial printing resources for Low and Medium Density Arrays , plus Assay Development and Analysis Services (Contract Manufacturing), using innovative fused silica capillary tube manifold assemblies on thin cover slips and on glass bottom 96-well and 384-well square microplates.
Design and development of the Array with positive and negative controls to ensure visualization of Arrays based on nearest neighbor thermodynamic modelling for match / mis-match DNA / RNA. Prototype design of the CCD scanner using large format CCD chips, with cooling provided by Peltier devices. The external illumination was provided by UV lamps.
TEXAS A&M UNIVERSITY, College Station, TX Doctorate 1993 Thin Films, MEMSOAKLAND UNIVERSITY, Rochester, MI Masters of Science 1986 Two-Phase Heat Transfer
INDIAN INSTITUTE OF TECHNOLOGY, Bombay, India B. Tech 1984 Mechanical Engineering
References Available Upon Request |
