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Flex Staff Bio's


Helen Anderson – Mechincal Engineer

Joined Flex Partners in 2006     

5 years engineering experience in:


·         General Surgery

·         Drug Delivery

·         Spinal Surgery

 

·         Plastic Surgery

·         Laparoscopic Surgery

·         Drug Tracking Systems

·         Implants

·         Microfluidics

·         RFID Integration

·         Technology Integrated Clothing

 

·         Articulation Design

·         Test Fixture Design

·         Magnetorheological Fluid Applications

 

·         SolidWorks & Pro/E

·         Mastercam

·         System Simulation & Math Modeling

·         Magnetic Flux Density Modeling

·         Patent Disclosures

 

·         Machining & Prototyping

·         CNC Programming

·         Casting/Mold Making

·         Dimensional Analysis

·         Design Function Analysis

 


Education:   BS, Mechanical Engineer with a minor in Business

 

Helen currently holds the position of Chair in the San Diego chapter of the American Society of Mechanical Engineers. During her university courses she also assisted teaching Solidworks and Pro/E Computer Assisted Design classes.



Adam M. Ariely - Mechanical Engineer

Joined Flex Partners in 2011

5 years engineering experience in:


·         Interventional Cardiology

·         Safety Sensing Systems

 

·         Opthalmology

 

 

·         Coronary Implants

·         Steerable Catheters

·         Surgical Instruments

·         Alarm Systems

 

·         Automated Drug Dispensing Systems

·         RFID

·         Hydrogels

·         Injection Molding & Mold Design

·         Thermoforming

·         Sheet Metal

·         Assembly Machine/Systems Design

·         Regulatory Agency Submittals

·         Medical Packaging Design

·         Rapid Prototyping

·         Machining

·         Solidworks

·         Animal Lab/Testing

·         High Volume Manufacturing

 


Education:     BS, Mechanical Engineering

 

 Adam is a member of the American Society of Mechanical Engineers.  He has sponsored numerous company supported student projects  one of which won the 1st place Mechanical and Aerospace Engineering Department Design Award in 2006.  While a student Adam cofounded Innovative Design and Engineering Applications (IDEA), a university sponsored engineering organization.



Louise Focht - Program Manager, Regulatory Affairs

Joined Flex Partners in 2010

26 years engineering, product development, regulatory affairs and quality assurance experience in:


·         Orthopedics

·         Ophthalmology

·         Plastic Surgery

·         Cardiovascular Surgery

 

·         Regulatory Affairs

·         Quality Systems Development

·         CE Mark

·         US Designated Agent

 

·         Upper & Lower Extremity Implants

·         Biomaterials

·         Bone Void Fillers

·         Rehabilitation Equipment

·         Brace and Splint Applications

 

·         Regulatory Strategy

·         510(k), HDE, IDE and PMA

·         Establishment Registration

·         Device Listing

·         Canada Medical Device License

 

 

·         Project Management

·         Risk Management

·         Biomechanical Analysis

·         Gait Analysis

·         FMEA

·         Equipment Testing

·         Verification and Validations

 

·         Employee Training

·         Standard Operating Procedures

·         Literature Reviews

·         Internal Audits

·         Suppler Selection/Qualification

·         Design Dossier

·         Technical File

 

 

Patents:   5 issued, 9 pending

 

Education:  BS, Mechanical Engineering, Professional Engineer

Louise has held engineering, quality assurance, research and development and product development positions with several medical device companies. She has been a cofounder of four orthopedic companies and President of one. She has been responsible for the introduction of more than 15 new orthopedic products, and is considered an industry expert in regulatory affairs. Louise has been a board member of the Orthopedic Surgical Manufacturers Association and the American Foundation for Surgery of the Hand.


Brandon Grant -Mechanical Engineer

Joined Flex Partners in 2011

Engineering experience in:


·         Solidworks

·         Mathematical Modeling

·         CNC & Manual Machining  

·         Prototype Development

 

·         Silicone Casting

·         Data Acquisition Systems

·         Test Development

Education:   BS, Mechanical Engineering, Materials Science

 

Brandon joined Flex Partners after graduation and completed his Professional Engineering  Engineer in Training certification in 2011.



Daniel Huynh - Senior Designer

Joined Flex Partners in 2005    

13 years experience in:


·         Solidworks

·         Mastercam

·         Silicone Molding

·         Photo Etching

·         Manual and CNC Machining

·         Manual Tooling Processes

·       Micro Scale Parts Production

 

 

·         Windows System Manager

·         IT Support

·         Website Support

 

·         Video Editing

·         Graphic Arts

Education:  BS, Industrial Design

 

Daniel has worked on a wide variety of technologies in his time with Flex Partners helping with prototype production and industrial design concepts. He is also an award winning metals artist and jeweler and apprenticed with a master enamelist before moving to San Diego.  His manual skills and familiarity with unusual jewelry manufacturing technologies has been critical to some of our rapid prototyping techniques.

At Flex Partners he works in the prototyping shop using CNC machine processes, cast silicone molds, along with traditional hand skills.

Knowledgeable in computer systems he also serves as the resident IT staff.


Belinko Matsuura - Project Manager, Senior Engineer
 

Joined Flex Partners in 1999

12 years engineering experience in:


·         Cardiology

·         Ophthalmology

·         Orthopedics

·         Gastroenterology

·         Urology

·         Plastic Surgery

 

·         Implants 

·         Surgical Devices        

·         Cadaver Studies              

 

·         Fluidics and Flow Cells

·         Nitinol Devices

·         Miniature Mechanisms

 

·         Stress/Strain Simulation

·         Mathematical Modeling

·         Computer Animation

·         Advanced Solid Modeling

 

·         Micro Machining        

·         Concept Development

·         Rapid Prototyping

Patents Issued:  1

 

Education:   BS, Mechanical Engineering

 

Belinko studied in Europe from 1993 to 1999 and is fluent in the Slovak Language. He is the recipient of several scholarship awards.

 

Belinko had worked with several early stage projects where he takes a raw product idea and develops engineering concepts for prototyping and evaluation. He has worked on some of the smallest implants ever developed for human use and recently he has been developing a complete line of spinal implants along with the necessary surgical instruments for their placement.



Dagmar Matsuura - Project Manager

Joined Flex Partners in 2002

33 years engineering experience in:


·         IV Delivery Systems

·         Cardiovascular

·         Surgical Devices

·         Detection Products

 

·         IV Pumps

·         Disposable Devices

 

·         IV Disposables

·         Implants

 

·         Project Management

·         Design Control

·         Document Control

·         Material Requirements Planning  Systems

 

·         Configuration Management

·         Quality Systems

·         Good Manufacturing Requirements

·         Quality & Regulatory

·         Research & Development


Education:     BS, (Equivalent) in Mechanical Engineering

 

Dagmar has worked for major medical companies where she planned, directed and coordinated activities for Corporate Document Control in compliance with ISO 9001; Quality Management Systems; FDA Quality System Regulation (21 CFR Part 820); EN 46001 Quality Systems for Medical Devices. She has extensive experience in document management systems and meeting quality system requirements.

 

Dagmar is fluent in Slovak and also speaks Russian.



Pamela Plummer - Office Manager


Joined Flex Partners in 2002     

23 years engineering experience in:

·         Client Invoicing

·         Materials Sourcing & Ordering

·         Accounts Payable

·         Human Resource Support

·         Payroll Management

·         General Business Support

          ·         Public Notary
          ·         "Startups" Office Support


Education:   AA Degree, Business

 

Prior to working at Flex Partners, Pam was employed at a major medical device manufacturer for 10 years.  Her position as Executive Assistant to the President and CFO consisted of a variety of tasks, compiling reports, scheduling and coordinating monthly meetings within the organization and with outside clients.  Pam also acted as liaison with the vice presidents within the organization and corporate customers.  Prior to that Pam held a position with another firm in the purchasing department and was the backup executive assistant to the President. 


 








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