Medical Device Engineer
Resume:
ASHISH UTTARWAR
******.********@*****.***
Phone: 001 650-***-****
OBJECTIVE Seeking a senior technical leadership position to integrate multi-disciplinary solutions for product development
PERSONAL STRENGTHS
- Proven ability to work in a mixed discipline R&D organizations to maintain current, and developing next generation products within an FDA regulated industry
- Demonstrated a track record of people development, brings out the best out of the team
- Willing to experiment and cultivate new ideas. Comfortable with ambiguity and uncertainty
- Gives clear direction to others when working in teams and allows others to accomplish their task effectively
- Challenges others to make the customer central to all thinking
- Maintains healthy relationships with vendors and service providers to get the best out of the collaboration
TECHNICAL HIGHLIGHTS
- Member of Silicon Valley start-up, purchased by Johnson & Johnson, that developed a platform technology for drug eluting coronary stents
- FDA compliant software product development, customer relations
- Scope of work includes engineering leadership for CE marking and FDA quality compliance.
- M.S. in Mechanical Engineering with major in Control Systems
- Involved in projects from proof of concept till commissioning
- Capable of multi-site technical support for globally run systems
- Systems automation expert for process control using computer vision and motion components.
- Extensive experience in design, development and validation of equipment for the regulated medical device industry.
- Broad practical experience with industry standard software tools (e.g. LabVIEW, Solidworks, AutoCAD, etc.)
- Hands on experience with integration of machine vision, motion control, PLCs in medical device manufacturing
WORK EXPERIENCE
Promoted to position of ever increasing responsibility and technical leadership
Sr. R&D Engineer, Conor Medsystems, Johnson & Johnson, Menlo Park, CA July 2008 till current
Role: Strategic lifecycle development
- Continue development of the Conor stent processing platform
- Support knowledge transfer activities to the manufacturing facility
- Identify and support development of necessary tools to improve production throughput
- Active in future generation of stent processing equipment design
- Support development, validation and deployment activities
- Recently appointed a lead role in process automation for catheter sub-assembly which is critical for stent delivery
R&D Engineer, Conor Medsystems, Johnson & Johnson, Menlo Park, CA Feb 2007 to June 2008
Role: Technology Transfer to the production facility located in Ireland
- Involved in software documentation, implementation for medical device fabrication machine
- Create test tools involving hardware and software for R&D testing purposes
- Assist test runs on medical device fabrication machines
- Identify improvements/modifications needed to improve efficiency in machine assembly and maintenance
R&D Engineer, Conor Medsystems, Menlo Park, CA April 2006 to Jan 2007
Role: Proof of concept and prototype development
- Member of the core team responsible for
o integrated machine for processing stents
o database architecture for managing the in-process and machine information
o network infrastructure needed for data communication
- Involved in implementing the concept to real life prototype
- Responsible for sourcing of components needed for system integration (eg: sensors, actuators, motion controllers, digital IO components etc)
- Developed the first prototype of the integrated controls for the machine
- Provided low level software drivers for integration of the hardware components in the larger software architecture
- Assisted in developing a robust software architecture which provided flexibility for modifications which is needed in prototype stages of the project
Junior Project Engineer, James Kring, Inc., San Francisco, CA Jan 2005 to Mar 2006
James Kring, Inc. is a National Instruments alliance member and working as a system integrator in bay area.
- Underwent extensive training on programming in LabVIEW and achieved “Certified Developer” certification
- Worked in a “consulting firm” environment which assisted in my career and personality development
- Assisted in software development, software testing, trouble-shooting, documenting software user guide
- Received hands on experience with Real Time, FPGA platforms
- Involved in requirement specification, design and implementation of machine vision system for an inspection of a semiconductor tool consisting of robot, stage, reticle handling mechanism with predominant use of LabVIEW for software development
- Developed instrument drivers for Standard Mechanical Interface (SMIF) for reticle handling system and XY Stage
- Assisted in improving the user interfaces and provide a good experience to users of the software
Maintenance Trainee Engineer, Grip Tight Packaging, India Aug 2000 – Jul 2001
- Carried out regular maintenance schedules of the web handling equipment used for printing wrappers
- Scheduled the periodic maintenance programs to avoid breakdowns
PROJECTS
Stent processing machine
A semi-automated medical device designed to deliver drug in Conor proprietary stent design.
It consists of:
- 6 axes motion control involving steppers and servos, vision acquisition and analysis
- approximately 40 Input/Output devices
- integrated barcode reader, cameras, pneumatic sensors and controllers, fiber-optic and infra-red sensors
- serial communication, data management and logging, user management
- CE marked and under FDA approval process
My responsibilities:
- perform feasibility study for variety of components to be integrated in the system
- create drivers in LabVIEW to integrate with main software
- implement software engineering to improve main software and make it modular and maintainable
- supervise software validation and testing procedure for FDA approval
Electro-polishing machine
A semi-automatic electro-polishing machine to processing Conor proprietary stents.
It consists of:
- cleaning, polishing and washing station for processing stents
- approximately 40 IOs, barcode reader, tank level sensors, fluid pumps etc
- touch screen operated user interface
My responsibilities:
- evaluate and assess hardware components to be used
- solely responsible for software development and management
- create LabVIEW drivers for agilent power supply, stepper motors, barcode readers
Dryer machine
A PLC based system having conveyor dryer functionality to dry the processed stents.
It consists of:
- PAC (Programmable Automation Control), NI Compact Fieldpoint
- stepper motor controller through a PAC
My Responsibilities:
- solely responsible for software development and management
- application developed using LabVIEW Real Time platform
- created diagnostic software to test functionality before implementation
Ancillary Systems
Developed and assisted in development of other supporting systems to provide tools assisting product flow from raw material to finished good stages.
EDUCATION
Master of Science in Mechanical Engineering, Oklahoma State University (CGPA: 3.3) Dec 2004
‘Balancing Inverted Pendulum ’
Involved implementing LabVIEW, LabVIEW Real Time and LabVIEW FPGA modules by interfacing NI 7831R PCI data acquisition hardware to Quanser inverted pendulum plant through NI SCB 64 connector
Bachelor of Science in Mechanical Engineering, Nagpur University, India May 2001
‘Orbital Pipe Welding’
Organized a complete operational study for orbital pipe welding process and developed a prototype model to explain the operation
COMPUTER SKILLS
LabVIEW, MATLAB / Simulink, C / C++, Visual Basic, Solidworks (basic), Tortoise SVN, Sketchup
ADDITIONAL INFORMATION
- Experience with line scan camera integration for machine vision
- Contribution and acknowledgement in book “LabVIEW for Everyone: 3rd Edition” written by Jaffrey Travis and Jim Kring
- Involved in Open Source LabVIEW community for improving programming skills by sharing and learning
REFERENCES
Available on request
Contact this candidate