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
joined
Flex Partners after graduation and
completed his Professional EngineeringEngineer
in Training certification in 2011.
Daniel Huynh -
Señor 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
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 PlanningSystems
·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.