• Evaluated material properties, design tolerance and processing capabilities into the overall design of the catheter.• Identified process potential challenges and establishes preventive measure to ensure reproducibility and repeatability• Provided support to R&D team members in helping translate ideas into actual design and process applications• Trains, mentors and provide guidance to technician and engineers in identifying the effective path in problem solving techniques.• Encourages and motivates team members to find not just good solutions but to find the best effective ways of processing prototypes• Identified process potential challenges and establishes preventive measure to ensure reproducibility and repeatability• Optimize catheter design not only to meet end user requirements but also ensures catheter design is manufacturable, robust, safe, and built with quality in mind. • Introduced new manufacturing process (equipments and methods process) to aid in catheter design development and to push prototyping design limits in discovering new design features and new processing methods.• Collaborated and supported R&D Peers and Cross functional teams to meet project requirements.• Built a collaborative environment w/ vendor that results into new discovery from both sides.• Incorporated feedback from both internal and external customers to improve catheter design and processing

• Developed new manufacturing process, procedures, inspection methods and production layouts for new and existing products.• Generates Test protocols and Test plan and generates reports for product verification and process validation testing.• Designs and develop highly capable fixturing fixtures for new and existing processes and test methods.• Mentors and provides guidance to Technicians and Jr Engineers regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.• Lead technical team members in the development of catheter devices, ensuring all R&D deliverables are met through all phases of development.• Led and Executed Process Validations, Managed Transfers products from R&D to production• Performs process improvements in manufacturing processes, procedures, production layouts for assemblies and equipment.

• Analyze processes and improve processes to assure robust and repeatable manufacturing process• Drafts and executes validation of product, equipment and process• Maintain current production processes and assist in smooth transfer of new process onto the production line• Designs fixtures for processes for new and existing products• Develop highly capable fixturing for existing test method process• Design, develop and qualify new custom tooling/equipment• Plans and performs Line layout as needed to keep line flow lean and effective.• Create and maintain documentation necessary to ensure consistent manufacture of products.• Executes and Supervises validation of product, equipment and process.• Performs root cause analysis for production issues using basic quality tools methods• Troubleshoots and repair equipment to prevent downtime.

• Designs fixtures for processes for new and existing products• Develop highly capable fixturing for existing test method process• Design, develop and qualify new custom tooling/equipment• Analyze processes and improve processes to assure robust and repeatable manufacturing process• Drafts and executes validation of product, equipment and process• Maintain current production processes and assist in smooth transfer of new process onto the production line• Plans and performs Line layout as needed to keep line flow lean and effective.• Create and maintain documentation necessary to ensure consistent manufacture of products.• Executes and Supervises validation of product, equipment and process.• Performs root cause analysis for production issues using basic quality tools methods• Troubleshoots and repair equipment to prevent downtime.

• Designs fixtures for processes on new products • Execution and Writing IQOQs, Equipment specification.• Provided support in the improvement of the Quality Procedure Equipment qualification and maintenance• Executes/ Supervises process operations qualification and process performance qualification protocols• Works with internal buyers and vendors to document new components or materials

• Assists Engineers on DOE’s setup as well as execution, testing and data collection. Collaborates with Engineers in brainstorming events and feasibility testing.• Assist Engineers in writing test methods and executes them to confirm that they work.• Investigates finished / in-process product in the production line to identify the root cause, trains operator as needed, make fine adjustments to machine to reduce defects or find new effective solutions and present it to engineers.• Develop and modify fixtures or tools for process improvements or ergonomic issues.• Works closely with vendors to manufacture developed prototype “manufacturing aids” for process improvements.• Performs IQ/OQ on test fixtures, tools and performs validation/qualification on components as needed. Supports Calibration and PM on the facilities (verifies and enters information on quality system and generates report for due for PM or CAL)• Creates DCR/CO via document control system to address issues that may arise or improvements on process that meets production requirements.

• Performs preventive maintenance and set-up on production equipment, fixture and tools.• Ensures the production environment is safe and clean.• Troubleshoots and adjust delicate manufacturing and/or inspection equipment/instruments issues effectively and efficiently.• Maintains adequate spare parts and materials for production equipment to minimize unexpected downtime.• Maintains Statistical Process Control Charts and re-calculates the control limits as needed.• Properly documents all maintenance, calibration, test, and validation activities in accordance with company procedures and regulatory requirements

• Conducts Job certification, recertification and maintains appropriate manufacturing/quality operation associate training records.• Adjusts training methods to match trainee’s learning style to build the trainees confidence on the operation they are learning.• Monitors and document Manufacturing Operation Associates Training performance and progress.• Executes corrective training to manufacturing operation associates when there are non-conformances or corrective action task.• Utilizes FMEA to increase awareness to the manufacturing associates of possible impacts of failure, if the process is not done correctly.• Performs Training on various functional, electrical and mechanical test methods for manufacturing/quality operation associate.• Provides input to the engineer or technician to determine the root cause, if there is a problem in the line.• Performs redline or corrections on WI document as needed and turns it in to engineer or supervisor for review.• Responsible for maintaining the QAP’s and WI’s documents are up to date in the work area and ensuring the superseded documents are purged from the work area.

• Knowledgeable with Title 21 and Fishbowl software.• Supports supervisor to generate and consume work orders.• Familiar with the Re-Work orders, NCR, DCR; able to execute rework orders independently.• Performs troubleshooting to find the root cause of the problem if RF generator is not working properly.• Performs Mechanical Assembly of the Generator.• RF Board Tuning - operates an Oscilloscope and Sweep Function Generator to acquire the resonant frequency; calculates and solders the right capacitor for the RF board to obtain a clean resonant frequency.• Responsible for training peers in documentation, assembly and finding the root cause of problems.• Performs Ablation Testing, Mock Ablation, Energy Delivery Test, Power Accuracy Test, Ratio Test, Relay Test, Temperature Accuracy Test, Functional Test, EKG Filter Test, EKG lead Test, Temperature Mode Test Power Mode Test, Electrical Safety Analyzer Test, 2kv Hi-Pot Test.• Programming PLDs, EPROMs and CF cards then populating them into the Main, Temperature, Display and RF Boards• Display Board Testing• ECG Boxes and Remote Control Assembly• Performs resistance and volt AC check with a use of a short test fixture on the ECG boxes

• Performs in process inspection using calipers, snap gages and tappi charts.• Performs Tensile testing via Instron Machine or Chatillon• Performs thermal bonding on Pebax materials (uses torch boxes & thermal welder)• Performs UV curing to bond a hypotube onto a pebax.• Operates manual and automated swaggers and crimpers• Accurately spaces electrodes using calipers, reticle or ruler.• Operates Resistance Welder to perform spot weld microbands to microwires.• Performs fine wire insertion into micro holes with use of fine fishing needle.• Operates EFD Dispenser that is used for soldering & adhesive application.• Proficiently handles micro parts under the microscope with accuracy and precision.• Performs hole punching using micro puncher to create holes.• Performs application of adhesive (IE. Epoxy & Loctite cyanoacrylate)• Proficient in handling various hand tools and micro precision tools.• Performs electrical continuity testing on RF Ablation Catheters via Cirris and HiPOT tester.

• Performs ultrasonic cleaning of the guide wires • Operates / Set-up Flattening Machine - Pneumatic Press • Performs dimensional Inspection on Guide wires after Flattening with the use of a Ruler and a Micrometer. • Performs minor machine maintenance to prevent machine down time • Operates / Set-up Pultrusion Machine - Coats the guide wire with black polymer • Operates / Set-up Hydrocoat Machine - Lubricate and Seal the black polymer coating of the wire • Inspection of Coated Guide Wires with a use of a computer connected to a friction tester machine - inspects the lubricity of a wire • Interpret test results from the computer • Tabulate and draw graphs of friction test results for records