Product development engineer
Resume:
Jean Santana
Product Development Test Engineer
Lowell, MA 01851
adyflw@r.postjobfree.com
Lean manufacturing experience Communication skills
Lead of NCA Cabinets
OSHA
Industrial Engineering
Work Closely with the Mechanical and Electrical engineers,Updating the ACL, WCL and Labels Work in a 6S environment
Product Development Test Engineer
Integra LifeSciences - Billerica, MA
November 2021 to March 2023
• Worked on SS Bonetip Design IQ/PQ/OQ Validation
• Performs complex tests of equipment, prototypes, processes, and products requiring understanding instrumentation and electrical test systems.
• Performs test protocols, computations, standard spreadsheet analysis, and presentation of data.
• Creates test protocols and procedures that can be qualified and utilized by other test resources.
• Work with subject matter expert (SME) to develop DOEs as needed.
• Evaluates designs and makes suggestions for improvements related to test needs and results.
• Maintains laboratory notebooks according to Integra practices.
• Demonstrates skill in the use and care of all tools and equipment.
• Maintains a clean, safe, and orderly work area.
• Follows all safety procedures.
• Testing will require work with animal tissue samples such as beef steak, calves liver, and pork bone or pig cranium.
• Simulation of surgical practices with manual cutting of tissue is performed with ultrasonic aspirator and monopolar coagulation systems.
• Cleaning of lab equipment and prototypes using disinfectants and autoclave systems is routine.
• working knowledge with statistical analysis software, such as Minitab.
• working knowledge with computer-based instrumentation, such as LabVIEW or MATLAB.
• Knowledge of neurosurgical products and relevant test methods.
• Knowledge of engineering documentation, test protocols, and laboratory procedures.
• Skills in personal computer spreadsheet, word processor, and engineering tools.
• Ability to carry out engineering calculations and analysis, make laboratory notebook entries.
• Ability to operate light machine tools, laboratory instruments, autoclave, and cleaning systems. • Ability to interpret displayed results on laboratory instruments.
Lead Assembly Technician
AMSC - Ayer, MA
March 2021 to October 2021
• Lead of NCA Cabinets.
• OSHA
• Quality assurance
• Industrial Engineering
• Positive Attitude, Self Motivator.
• Strong working knowledge on Microsoft word
• Excellent reading, speaking Written skills in english and spanish. • Problem solver with the passion for detailed project management. • Trained new employees to build the TBC and NCA Cabinets.
• Excellent Teamwork, Communication, Interpersonal and Leadership Skills.
• Assembled the brain of the Wind Mills TBC and NCA Cabinets.
• Testing NCA and TBC Cabinets, Random Checklists, continuity test, 3 Phase Testing, High Voltage troubleshooting.
• Exceptional Attention to Detail.
• Cut rails, wire ducts and used Power Tools to install on TBC and NCA Cabinets.
• Strong Electro-Mechanical and Opto-Mechanical Orientation.
• Experience in ISO 13485 Certified and cGMP Organizations.
• Advanced Level Skills in MS Word, Excel and PowerPoint such as Keyboard Short Cuts, Creating Forms, Table Techniques, Working with Images, Text, and Pivot Tables.
• Proven Problem Solver with Multitasking Skills and the Ability to Prioritize tasks to Align with the Goals of the Department and Organization as a Whole.
• Advanced ability to Read, Interpret and Understand Engineering Documentation including Assembly Drawings, Detailed Component Drawings, Optical Schematics, Electrical Schematics, Pneumatic Schematics, and Wire Run lists
• Proven ability to quickly learn and understand complex topics.
• Ability to quickly grasp complex concepts and make them easily understandable in text and pictures by using Microsoft word.
• Worked on improving the quality of the product and the building process.
• Work Closely with the Mechanical and Electrical engineers,Updating the ACL, WCL and Labels making sure this new project gets going in the USA
• Hi Pot Testing, Data Collection,Isolation testing
• New Product Development, Work with engineering correcting/updating the blueprints,AI,ACL,CCL and the WAL.
• Used Microsoft Word to Create Work Procedures, Test Procedures and Checklists.
Used the ACL to collect all my components and install them onto the NCA, TBC and CCA Cabinets. Followed the blueprints to make sure all the components were in the correct location and spacing Routed all the wires by a color order and made sure they were the correct length any that were too long or short i worked with the engineers to make the correction
Performed the WCL to make sure all wires are in their correct locations and make sure none are missing
Authorized to work in the US for any employer Work Experience
Assembler Technician 2
Cogmedix - West Boylston, MA
March 2019 to October 2020
• Positive Attitude, Self Motivator.
• Excellent Teamwork, Communication, Interpersonal and Leadership Skills.
• Performed weekly audits in different cells to make sure they were 6S Compliant and up to the cogmedix company standards that I was complimenting
• Exceptional Attention to Detail.
• Strong Electro-Mechanical and Opto-Mechanical Orientation.
• Experience in ISO 13485 Certified and cGMP Organizations.
• Advanced Level Skills in MS Word, Excel and PowerPoint such as Keyboard Short Cuts, Creating Forms, Table Techniques, Working with Images, Text, and Pivot Tables.
• Proven Problem Solver with Multitasking Skills and the Ability to Prioritize tasks to Align with the Goals of the Department and Organization as a Whole.
• Advanced ability to Read, Interpret and Understand Engineering Documentation including Assembly Drawings, Detailed Component Drawings, Optical Schematics, Electrical Schematics, Pneumatic Schematics, and Wire Run lists
• Solid Works Experience
• Over 50+ pounds heavy lifting
• Manufacture Medical Devices, Laser Assembly Sub-00191, Sub 00126, Sub 00193, Top 17 and Complete Arm Assembly, Side Panels V2 and V3, V3 Arm Packaging, Power Supply Assembly.
• Epicor Experience, Serial Matching, Issue Material, Return Material, Job Closing,Serial number Tracker and MES.
• Level the Laser with Bulls eye Tool and Leveler.
• Used Torque Drivers/Wrenches,Jaw Pincer Pliers,Phillip/Flathead Screw Drivers,Wire Cutters,Voltage Meter,Jaw Pincer Pliers
• Clean and Install Galvo and Collimation Optics Lenses under a Flow Hood.
• Followed BOM Procedure, 21 CFR 820 and ISO 13845 to be in Full Compliance with Company Policies. • Performed Air Leak Testing.
• Part of Audit Team, Maintained a 6S Environment,Managed Team made sure Everyone had the Correct Tools,Screws, Materials to Maintain the Work Flow and made Shadow Boards to keep Tools and the Tool Box Organized.
• Communicated to Engineering on Making Updates and Changes to BOM
• Worked with Manufacturing Engineers and Program manager, Project Manager, Troubleshooting NCR Reworks created by engineering Team and Customer ECO.
Laser Technician 4
Analogic Corporation - Peabody, MA January 2018 to November 2018
- Work on FBI Secret project ANDE
- Build decks from scratch with all optical components, different lense sizes, mirrors, Galvanometer, PMT and laser.
- inspect all lenses
- inspect laser signal
- align laser to PMT
- Worked in security Department
- Tested and built analogic's connect aviation bag screening system
- Tested analogic's AN6000 magnetic resonance imaging products
- Worked in the BK Ultrasound Department
- Built BK Ultrasound subassemblies
- Worked in Box assembly Motion control Department -Tested different AC and DC power boards
Test Technician 4
L3 Communications, Londonderry, MA
November 2016 to April 2017
• Received field returns entered device S/N and customer name into SAP to keep Product Life inventory
• Took a class Certified in Soldering.
• Programmed software and Firmware on Squad Range Finders, Programmed boards at Powerset station.
• Installed windows, Digital Boards, Power Boards, Adjusters, used Epoxy, UV Glue, UV Gun, Black Epoxy, recorded daily issues in a record book on stations.
• Assembled Squad Range Finder complete units fronts, Housings and rears, cable connections, Glued connectors, added
• Ran Verifications and Post Thermal Verifications for SRF-040 and SRF -044 tri-lasers, Co-alignment station, Vis/IR Station, TX Station, Range station
• Focused SRF-044 Tri-lasers Vis/IR lenses on the Vis/IR Station, Focused SRF-040 RX Lenses to APD's on the TX Station.
• Ran Group A ESS Verification Test and ESS Post Thermal Verification Test for the SRF-002 on the Powerset, Illuminator, Co-alignment, Range, Travel and TX Stations.
• Ran Group C Monthly test for SRF-001 units on the Powerset, Illuminator, Co-alignment, Range, Travel and TX Stations.
• Loaded/unloaded SRF-040 and SRF-044 units in the Thermal Chamber and Humidity Chamber, Loaded/unloaded Group A SRF-002 and Group C SRF-001 units in the ESS Chamber.
Optical Technician
HeadWall - Fitchburg, MA January 2016 to September 2016
- Used software's Spectro Tester, Finale 2,
- Mixed Chemicals Epoxy and RTV, Primer Prep Mirrors, Install Filters
- Assembled Spectro Instrument X-Rite- Grating cell, Detector, Slit, Mirror, PCB Boards - Programmed oven to run X-rites temp Cycles
- Flocking- X-rites Enclosures, Detector Holders and Grating Cells
Grating Clean Room
- Class 100 clean Room
- Cleaning Grating Station, Spinning Station, Grating Station
- Laser Room, Shooting the Gratings with the Laser
- Developing Gratings
- Complete Clean room suit
- Used software Maxx to update company grating inventory
- Set up labs, Mixed chemicals
- Programmed Oven For Grating Cycle
Clean room Fiber Tester/Assembler
Syneron Candela - Wayland, MA
July 2015 to January 2016
Inspected, cleaned and Tested MGL, VBEAM, VBEAM2, GLPRO and VPYAG Fibers on the Gentle Laser,
VBEAM Laser and VPYAG Laser.
- Programmed Fiber PCB Boards with software created by the software Engineering Department at Syneron.
- Can Read and comprehend schematics, bill of material and Pick list.
- Moved and Completed Fiber and Optical assemblies in the software Oracle.
- Optical Assembly and Optical alignment
- Written and verbal skills Proficiency
- Can you use hand held microscope
Quality Technician/Inspector
Vecna Medical - Woburn, MA
April 2014 to October 2014
• Build and test 32 & 42 in. IQD's, Digital sign Wall & Pole Mount.
• Head Assembly and test them in burn in rack, Line Tube assembly. • Worked in warehouse packaging, Loading and unloading UPS Trucks. • soldering cpu boards, perform 5 S after every lot is done.
• Filled out traveler papers for all products.
Recall Technician - Temporary
Nova Biomedical - Billerica, MA September 2013 to November 2013
Involved in a regulatory compliant FDA recall of blood glucose test strips.
Initiated RMA log sheets by confirming consumer demographics and expected product return packages and documented contents by part, lot and serial numbers in the software IRMS.
head subassembly
Assembler/Production
Clean Room
Volt - Westford, MA
March 2012 to July 2012
• Worked at lightlab in a sterile environment cleaning and packaging products.
• Dealt with a lot of delicate paper work and followed the procedure.
Manufacturing
• Prepared the machine, ran wires neatly, installed pc's, power supply, screws, head subassembly. • wiring, utilize epoxy, component installation, soldering and cable harnessing on assembly units
Field Service Technician
Seica Inc - Salem, NH
July 2011 to November 2011
• Managed all products that came into and out of inventory on software called imagic.
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