RD tech and ME technician
Resume:
Huong Dang
SAN JOSE CA
*************@*****.***
SKILL
• Catheter assembly, prototyping, production settings, and process improvement.
• Nitinol stent design testing
• Worked in manufacturing environments (clean room) as a process/ manufacturing/ operation/ materials
• Design simple tooling/fixtures with SolidWorks. Fabricating fixtures using 3D printing
(FDM/SLA)
• Perform testing of prototypes and components following protocols and processes
• Prepare test samples (products/materials/solutions) for routine and qualification testing
• Assist engineering teams in obtaining the necessary supplies and components
• Works with other technicians and manufacturing engineers to improve assembly efficiency, improve product quality, reduce manufacturing cost, and validate release assembly/fabrication documentation
• Understand engineering drawings and attention to detail in process procedures
• Uphold safety, Quality Management Systems (QMS), Environmental Management Systems (EMS) and technical concepts
• Maintains a safe work environment, meeting company safety policies and all regulatory requirements.
• Perform scheduled maintenance and calibration on equipment (PMI) for both production and R&D teams, review and update certificates to control system (BM)
• Works as part of the manufacturing team to develop, evaluate & improve various processes
• Leads the production of several processes /lines in a highly technical environment and is responsible for the line success
• Evaluate daily/regular plant operating performance and advice on changes in operating conditions that will improve efficiency and quality
• Lead a team of individual professionals to meet quality, cost, delivery and responsiveness requirements
• Testing and troubleshooting of subassemblies and final assembly
• Hands-on experience with manufacturing and assembly techniques of medical devices.
• Collaborates with Operations, Design Engineering, and Engineering to improve product manufacturing and serviceability.
• Monitoring for quality during processing, in-process inspection, and troubleshooting technical issues that occur during the system's final test, identifying the root cause, and correcting the problem in support of success
• Experience using Device History Records, MPI, QAD, BOM, GDP, GMP, BM, MTF.
• Support quality assurance activities, including, but not limited to: NCMRs and CAPAs, IQ (Installation Qualification) OQ (Operational Qualification), PQ
(Performance Qualification)
• Performs internal support duties including stocking consumables/materials
• Ability to work well under pressure and to meet multiple and competing deadlines while maintaining a cooperative working relationship with others
• Reliable, responsible, resistant, hard-working, and fast learner, communication WORK EXPERIENCE
Silk Road Medical, Sunnyvale, CA October 2018 – Present Research and Development Technician II
Manufacturing Technician II
• Partner with engineers and other technicians to assemble functional prototypes and provide feedback on assembly process and design
• Assist engineers with process design, development, and optimization
• Build introducer sheath body prototype samples following R&D engineering team design, supporting concept down selection, correcting and improving upon any documents related to the assembly process at the required quality standard
• Execute stent design testing, including Visual and Dimensional inspection, Kink resistance test, Radial Force Test, and document results and observations, allowing for successful Design Freeze of stent design
• Performed design evaluation and production monitoring testing with Instron tensile tester, Uson leak test, Keyence VHX vision system, Stent radial force tester, Micro-Vu Vertex
• Co-develop test method with engineering team to ensure testing can be done consistently; executed test method evaluation and validation following engineering team supervision
• Provided support during DV and production build throughout Multiple Generations of Neuroprotection product activities including:
o Cross-training other technicians to build a product or follow an established assembly process.
o Responsible for ensuring that work order protocols are allowed, and that order paperwork is completed as the work is performed
o Follows established procedures for routine work and may require instructions on a new assignment
o May conduct in-process quality checks to ensure that items built are to establish high-quality standards
o Provide input on manufacturing challenges and potential yield loss to the manufacturing engineering team
o Identifying areas of production that can be improved or increased to process activities, methods, and procedures on new assignments o Utilize hot box equipment, microscopes, and equipment, Coil Winding, pad print, oven, small hand tools and nozzles, adhesives, and UV curing systems such as general Catheter Assembly under a Microscope, Bonding, Soldering, Heat, Tipping, Flaring, Packaging, Labeling…
o Complete build of venous and arterial sheath bodies, flow controller sub- assemblies, packaging, and materials handling…
o Maintain safe work and clean room integrity via proper gowning techniques and adherence to cleanroom environment practices and procedures. o Conduct technical assessments for hiring and training, including certification for new operations
o Trained new production assemblers and integrated them within the production line,
o Process update documentation experience (GMP, GDP, MPI, LHR, DMR (Device Master Records), Validation Documentation, Inspection Records.) o Support production for testing and inspection to ensure parts and assemblies meet production specifications
o Teamwork, communication, working extra hours when needed, and following
(SOP) standard operating procedures
o Experience building medical devices from start to finish following Good Manufacturing Practices (GMP, GDP), ISO 9001, and FDA Compliance to 21CFR820 and ISO13485.
Creganna Medical, Campbell, CA Assembler September 2017-September 2018
• Built and reworked catheter sub-assembly and final assembly of catheters
• Worked on catheter shaft lamination process, tip forming, and junction fusing.
• Perform final packaging.
• Built the soft tip attached to the line marker band using Dymax UV curing.
• Inspected material using the microscope.
•
Avantec Vascular Sunnyvale, CA Assembler 2015 – 2017
• Utilized extensive experience with microscope, caliper, pin gage, snap gage, hot box, and other catheter development tools.
• Worked on all phases of vascular catheter build processes.
• Worked on coil bonding, sealing using heat or adhesive, coil zapping ball, coil secondary winding, coil attached suture/melt ball, and fine core-wise soldering. Education
Nguyen Dinh Chieu High School-Viet Nam
University of Cong Dong Tien Giang – Vietnam
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