A results-oriented technical leader and permanent resident of the U.S with experience in manufacturing process technology development, device assembly, printed circuit board assembly, process engineering, academic research and lean-sigma for experienced engineer role.

Summary

Device process development, R&D, NPI

Led from proof of concept to market launch.

Led multidisciplinary cross-functional engineering project

Design for Excellence (DFX/DFM/DFA)

Failure Mode Effects Analysis (FMEA)

Identified and implemented external process technologies

Lean sigma expert - Complex data analysis and statistics

Process & equipment validation. MVP and IQ/OQ/PQ

RoHS and PbSn PCBA Processes

Advanced plastic processing & material science,

Proprietary polymer processes & UV curing

Managed customers & vendors

Planning, scheduling, monitoring & closure of projects

Supplier selection and its quality improvement

Sourcing, financial and strategic assessments for RFP.

Owned CAPA for medical device

Expert in Bill of Materials BOMs & ECOs

Train & mentor associates

Technical Skills

● DOE ● ANOVA ● SPC ● Cpk ● DMIAC ● Hypothesis Tests ● Technology Landscaping ● Heat Transfer ● Laser Welding

● Product Development ● Contract Manufacturing ● Injection Molding ● Extrusion ● Ultrasonic Welding ● Quality Control

● Automation Development ● Material Characterization Methods ● Metrology Development ● Wire-Harness Assembly

● SMT/PTH ● Electrolytic Capacitor ● Microelectronic ● Polymer Structure & Property ● Financial & Strategic Assessment

● Electromechanical Assemblies ● Root Cause Analysis ● Problem Solving ● Fishbone ● 5Why ● Concept Development

Regulations Familiarity

● IPC 610 ● IPC 620 ● 21 CFR 820 ● ISO 13485/9001

Software Skills

CADD: ProE ● Windchill ● Solid Works ● AutoCAD ● Ansys

PCBA: Gerber Tool ● Valor

Language: Matlab ● C

Packages: MS Project ● MS Office ● MS Visio

ERP Tools: Ariba ● JDE ● Agile ● SAP

SPC: Minitab

Education

Master of Science (Manufacturing Engineering) University of Missouri-Rolla 2003

Bachelor of Engineering (Production/Mechanical Engineering) University of Madras, India 2000

Professional Development Certifications

Plastic Engineering (4 courses) University of Massachusetts Lowell 2014

Project Management Praxis 2012

Managing Product Design & Development Northwestern University 2011

Process Validation of Medical Device CfPIE 2006

Certified Six Sigma Black Belt ASQ Jan'11 - Jun '14

Detailed Work Experience

Product & Process Design and Development Consultant June 2014 – Present

Developed assembly process which is a combination of laser welding, magnet and adhesives for next generation left ventricular assist system

Developed a vacuum based glue filling process. Developed instrumentation and qualified the same

Applied scientific principles on design review and provided DFX feedback to R&D team. Worked on Tolerance stack-up analysis

Developed fixture design for critical device assembly. Used Solidworks developing metrology probe for profilometer.

Hands on worked with metrology instruments profilometer, CMM, MagCAM and tensile tester.

Qualified metrology system using Gauge R&R and ANOVA studies.

Worked on system architecture development for a pill delivery system. Worked on device DFX.

Remediation consultant for functional and design requirement document and DFMEA for orthopedic and endoscopic product

Alcon Research Inc (A Novartis Company) Senior Process Development Engineer April 2012- May 2014

Led technology assessment and development for making next generation and legacy Intraocular Lenses (IOL)

Lead a team identifying technology and characterizing UV light for photo based polymer curing process of next generation IOL products

Developed design transfer procedure from R&D to Manufacturing and sampling plan for high volume production using Z1.9 table

Led a cross functional team and external team on a CAE/FEA (Sigma Soft and Moldflow) simulation based design development of high precision molding components

Developed MVP that envelops test method validation and IQ/OQ/PQ protocols and reports for equipment.

Automated dimensional inspection of IOLs using vision system. Qualified the system using Gauge R&R and ANOVA studies. Implemented the system in value stream

Lead a team of MIT engineers in identifying a multi-disciplinary method measuring residual stress left over in PP wafer

Responsible for implementing FMEA in process development group, systematically assessing and solving problems for a product that was going out of R&D team to manufacturing

Partnered with Femtosecond laser technology provided in developing polymer ablation process

Partnered with ultrasonic coating technology provider in developing polymer based coating process

Reviewed process development variable data as a six sigma expert

Plexus, Lead Mechanical Engineer/Process Engineer Feb 2006 – Apr 2012

Recognized as subject matter expert in engineering projects and proficient technical project manager in medical device with substantial complexity and scope. Contributed significantly to the product and process development of medical and commercial products from concept to launch, pre and post clinical in RoHS environment. Worked on fluidics, mechanism, mechatronics, PCBAs and wire harnesses.

Led the design development, FEA analysis and prototype development of complex assembly, functional test strategy and PCBA & multi lumen wire-harness assembly process development of capital medical instruments

Managed new product releases within value stream and ensure successful transition to volume manufacturing through process validation

Developed procedures and process specifications for manufacturing new assemblies based on product and component material specification

Assisted in product developed and design alternatives for electronic assemblies by performing DFA/DFM and building prototype. Identified process performance issues and implemented solutions

Authored Design for Excellence (DFX), assembly components material selection guideline, NPI guidelines for electromechanical assemblies and clean room SOPs

Responsible for directing cross functional project stakeholders including engineers, technicians, production associates and buyers. Worked with purchasing department for vendors/supplier selection and supplier quality improvement.

Process validation of medical device and microelectronics that go into medical devices using variable and attribute data Cpk. Developed MVP that envelops test method validation and IQ/OQ/PQ protocols and reports.

Created new assembly line layout, balanced line, identified head count required and line capacity

Process owner of printed wiring assembly processes. Responsible for implementation of advanced manufacturing process initiatives from corporate. Developed specialized thermal treatment of electronic components before they are used in assemblies

Approved thermal profiles for RoHS and PbSn soldering process considering heat, component specification and PCBA material balances.

Created paste height measurement program in automated instrument and kept track of SPC chart taking corrective action to machine set up.

Performed DOEs to develop wave solder process and component joining process; Performed comparison of means (T-test) to compare microelectronics processing instrument’s capability

Demonstrated technical leadership and drew conclusions and recommendations for design and process based on comparison of means, hypothesis and confidence interval

Performed failure analysis of assemblies in lab environment and took corrective actions on processes

Made recommendation for capital equipment purchase based on new product configuration

Led design for excellence projects for fluid management system used in orthoscopic surgery, hand held wound therapy device, bed side massage therapy device, hospital glucose monitor, modem termination system. The projects comprised of guidance to customers on IPC 610, IPC 620, instrument cleanliness, assembly fool proofing & simplification, accommodating CSA and UL regulations, electrical safety principal and instrument validation and verification

Process & Design Development Consultant

Gentra Systems via SVK Systems Sep 2005 to Jan 2006

Worked with a team of R&D engineers designing and developing reagent filling equipment and its web cutting & heat sealing mechanisms. Developed vacuum drying for a biomedical process

Medtronic via SVK Systems Oct 2004 to Aug 2005

Automated electrolyte dispensing station for capacitor (Class III) manufacturing line. Improved the yield of capacitor packing by introducing precision tape cutting device. Qualified automation line establishing confidence using statistical techniques

Steris Corporation via Manpower Apr 2004 to May 2004

Designed ceiling support system for medical equipments used in electrical & gas supply systems for Intensive Care Unit (ICU)

Missouri University of Science & Technology Research Engineer Jan 2002 – Mar 2004

Engineering Management Department: Developed a warranty cost optimization math model using Mahalanobis Distance & Dr. Ragsdell's warranty cost model. Developed a software/Graphical User Interface (GUI) in Matlab as a part of research completion.

Mechanical & Aerospace Engineering Department: Developed concepts for prefilled syringes with Prof. Avula Xavier

Jayanth Engineering, India Design Engineer – Full-time May 2000 – June 2001

Designed industrial valves that are used in oil and food processing industries. Developed jigs & fixtures. Responsible for product risk mitigation and production floor industrial engineering initiative

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