SANJAY

MEDICAL DEVICE DESIGN & REGULATORY

AFFAIRS.
LINGOT
BACKGROUND

Design Development & regulatory Manager for Medical industry. Finite element analysis of
structures, mechanism design and 3D modeling. Work experience of compliance of ISO-13485 &
auditing ISO 9001:2000 internal quality audits, working knowledge of MDD 93/42/EEC & responsible
for regulatory affairs including FDA & CE certification process.

Successfully completed the Design & Development of Cruciate Retaining Knee implant system and
Posterior Stabilizing Knee implant system from scratch to final finished products Responsible for
design and development of instruments for hip surgery and also the concept development of
minimum invasive surgery navigation system for hip surgery

Completed FDA Premarket notification (510(k)) of three types of hip systems (Cemented type,
noncemented type & bipolar hip system), FDA 510(k) for highly crosslinked UHMWPE & FDA 510(k)
for spine implant systems & helped colleague engineer in certification of CE for hip systems by
preparing technical construction file. Involved in the Korean Food & Drug Administration (KFDA)
certification of hip implant systems as a class-III device
EXPERIENCE

Strong communication skill, negotiation skill, vendor development skill, customer focused, ability to
1999
Freelance New Media
manage multiple projects at a time, ability to work in a stressful situation, Excellent technical
present
problem solving Developer
skill, interpersonal skill, motivational skill & manpower handling skill.

20012003
20002001
19971998
19941997

Creative Technical
Director
Active Edge New Media,
Nashua NH
New Media Designer
Interactive Factory, Boston
MA
Art Manager
EA Sports/Tiburon, Maitland
FL

EDUCATIO
N
Project Lead / Game
1996
MFA Computer Graphics

AREAS OF INTEREST
Medical device design &
development
FDA 510k & CE marking
ISO 13485/ISO 9001
Medical device testing
Solid Work, Inventor & AutoCAD
FEA-I-DEAS
Mechanism design- ADAMS
MS Project ,Word & Excel
Manufacturing
People Management

Designer
Design
Qualia Games, Somerville MA
RIT School of Art & Design

1992
MS Electrical Engineering
University of Rochester
1990
BS Computer Engineering
Worcester Polytechnic
Institute

CONTACT
David Seah :: Blah Blah Blah
www.davidseah.com
603.555.1212