Sreya Chatterjee has over 6 years of experience in engineering and quality processes in the medical device industry. She has worked at Stryker Corporation in both the US and India, leading validation efforts to ensure successful product launches. Her areas of expertise include measurement system analysis, installation and operational qualification, statistical quality control, and medical device regulations. She has experience with risk analysis, failure mode analysis, computer system validation, and audit preparation.

1. Phone: +1 2695682934 304 Candlewyck Dr, Apt 1414, Kalamazoo, MI-49001
Email: sreya.chatterjee1986@gmail.com
Sreya Chatterjee
With more than 6 years of engineering experience in achieving improved quality and performance of
automated electromechanical test systems, production equipment, computer systems and bio-analytical
methods, I bring strong domain knowledge and expertise of medical device validation in order to drive
quality processes towards successful launch of winning products. Besides being analytical and results
driven, I am a quick learner of new technology and processes, and am a highly motivated team player.
Areas of expertise:
Measurement System Analysis
(MSA)
Installation/Operational
Qualification (IQ/OQ), FAT, SAT
Statistical Quality Control
(SQC)
CQE (certification in progress) Statistical Process Control (SPC) Medical Devices
Risk Analysis Project Management Design Input/Output Verification
Gage R&R Pareto chart, 5 why’s, 6 M’s Process Capability (Cpk, Ppk)
Change Management DMAIC Computer Aided Design (CAD)
Experience
1) Stryker Corporation, USA
Designation – Sr. Test Engineer
Role – Validation Lead
Duration – 3+ years (2013 to present)
Achieved cost-effective and successful launch of products covering 80% of divisional portfolio,
including neuro-surgical power tools, fluid management systems, ultrasonic cutters,
interventional spine and surgical hoods, by validating product test systems.
Led critical risk analyses, failure mode analysis (FMEA) and qualification of automated
electromechanical test systems and robots for successful product release to market.
Drove success of multiple FDA and TUV Audits by ensuring zero finding on the quality system
documentation created by me.
Enhanced Quality System Requirements (QSR) throughout the business unit by mentoring
validation authors on FDA guidelines, quality processes, CAPA closure.
Accelerated Computer System Validation of a novel PLM and complaint analysis software by
leading cross-functional team participation of 6 members.
Led validation activities to achieve compliance status of Stryker Bio-analytical lab (ISO
certification) as a Stryker Validation expert.
Spearheaded the successful launch of first Stryker e-validation system by qualifying the software
and training multiple users, thereby saving cost of external training.
Ensure timely delivery of test systems by driving project management responsibilities.
Reduced redundancy and cost in quality processes to standardise 25+ Gage R&R studies across
business divisions.

2. 2) Stryker Corporation, India (supporting Stryker Orthopedics, USA)
Designation – Design Engineer
Role – Design Lead
Duration – 3 years (2010 – 2013)
Drove design, development and release of specialty instruments using risk analysis, FDA
guidelines and product verification and validation activities.
Innovated novel anthropometric studies on varied population using 3D image analyses to
develop customized knee implants.
Drove multiple remediation activities to support product engineering of orthopedic implants.
Accelerated spread of product domain knowledge within the organization by conducting
educational academies and mentoring colleagues.
Skills
Skill Tools Experience Certification
Technical skills
Industry Quality standards FDA 21 CFR 11, 210,
820; ISO 9001; 13485
3+ years AAMI certification
Risk Management FMEA, RMF 5+ years Stryker Certification
MSA, Gage R&R Minitab, SPSS 3+ years Minitab certification
Process Capability Cpk, Ppk 3+ years Minitab certification
Validation – Equipment
Qualification
IQ, OQ, Risk Analysis,
DIOVV
3+ years Stryker PL3 (expert level
certification)
Validation – Computer systems e-validation system
(Valgenesis)
3 year Stryker certification
CAPA, Audit FDA, TUV 3+ years Stryker internal training
Product Life Cycle
Management(PLM)
Windchill,
PTC©Integrity 10.0
6+ years
1 year
Stryker internal training
Stryker internal training
CAD/CAE, GD&T ProE, Gambit 6+ years ETI certification
Imaging and 3D Reconstruction MIMICS 1 year Materialise certification
FEA (Finite Element Analysis) ANSYS, LSDYNA 2+ years University experience
CFD (Computational Fluid
Dynamics)
FLUENT, COMSOL 2+ years University experience
Programming ANSI C, MATLAB 7,
SAS, UNIX, DBMS
2+ years University experience
Domain skills
Conduct VOC Collecting user needs 5+ years Stryker experience
Design validation Live surgery and 6+ years Stryker experience

3. Education:
Examination University/Board Institution Year of Passing CPI /%
M.Tech IIT Kanpur IIT Kanpur 2010 8.33
B.Tech WBUT HITK, Kolkata 2008 9.16
Intermediate ISC Salt Lake School, Kolkata 2004 91.8
Matriculation ICSE Salt Lake School, Kolkata 2002 93.1
Engineering Projects:
1. Master of Technology Dissertation - Computational Modeling of Flow through the Gastro-
esophageal Junction in Health and Disease (2009 – 2010)
3D modeling & simulation of human gastro-esophageal junction using spatio-temporally moving
mesh technique in ANSYS FLUENT.
Geometrical shape optimization using the MATLAB Curve-Fitting & Spline Toolbox
2. Entrepreneurship Project - Concept development of high-grade & low-cost glucose syrup unit using
integrated 2-phase bioreactor system (2009)
Designed, analyzed using FEA and budgeted a novel reactor to attain greater yields of different
product grades at lower costs and conducted preliminary market study
Certifications & Workshops:
Stryker Corporate Validation Program – PL3 certified
AAMI Certification on Industry standards on Validation of Medical Devices – May 2015
Geometric Dimensioning & Tolerancing (GD&T) and Stackup certification from ETI - Sep 2010
“Intellectual Property Rights Sensitization” certified by Federation of Indian Chamber of Commerce
and Industry (FICCI) at IIT Kanpur - 2009
Awards and Achievements:
Secured an All India Rank of 96 out of 13,000 students (99.27 percentile) in national pre-Masters
qualifying exam GATE - 2008
Secured top 30 rank throughout India to for a summer research program by JNCASR at Indian
Institute of Science (IISc) Bangalore - 2007
Best Speaker in Stryker Toastmasters impromptu speech.
Positions of Responsibility:
Mentored validation engineers on FDA guidelines on Equipment Validation and Stryker e-validation
system.
Successfully held position as Treasurer of Stryker Women Engineering group in promoting
Diversity and Inclusion.
Cadaver labs
Anatomical knowledge Knee and Hip anatomy 6+ years Stryker Knee Academy