Design Medical

JAYESH ZALAVADIA

Phone: 609-***-****

E-mail: ******@*****.***

CAREER PROFILE

BIOMEDICAL ENGINEER (R&D, NEW PRODUCT, MANUFACTURING, PROCESS, QUALITY,

REGULATIONS)

NPD DESIGN CONTROL eDHF VALIDATION VERIFICATION CSV pFMEA/dFMEA

DESIGN TRANSFER DMR MANUFACTURING SPC STATISTICAL TESTS QSR CAPA

DCC/DCO Title21CFR820 ISO 13485/14971

Bachelor's degree in engineering, Diploma in software engineering, Trained

on various medical device regulations & applied statistics/statistical

process control, also trained on Human Anatomy & Physiology, attended

various Human Cadaver Labs for training and R&D purpose, as well as many

years of progressively responsible hands-on and management experience in

the Research & Development of Medical Devices, New Product Design and

Development, Design Control, authoring various design control documents

and maintaining eDHF, Process Design, various Validation/Verification

activity, Process Validation, Computer System Validation (CSV, IQ, OQ,

PQ), Risk Management, pFMEA/dFMEA, Troubleshooting, Root Cause Analysis,

Process Control Plan, Design History File (DHF), Design Transfer, DMR

flow diagram, Manufacturing, update Device Master Record (DMR), auditing

Device History Records (DHR), Document Control Center, Document Change

Order, Process Capability (Cp/Cpk), various Control Charts, Design of

Experiments, Various Statistical tests of significance (z-test, t-test, F-

test, ANOVA, chi-square, etc.), FDA QSR, ISO 13485:2003, ISO 14971,

Regulatory Compliance, and Quality Control under an FDA/ISO regulated

biomedical industries.

KEY SKILLS

V Excellent entrepreneurial spirit with strong integrity & ethics,

expertise in managing/directing/supervising as well as direct hands-on

experience in business operations, experience in

electrical/mechanical/quality/process engineering and R&D in Medical

Device Design & Development and manufacturing

V Experience in Medical Device Design & Development and Manufacturing,

Design Control, Process Design, Design of Experiments, Risk Management,

Various Statistical Methods, Process Validation, Computer System

Validation (CSV), Troubleshooting, Contiguous Product/Process

improvements, Document Controls, FDA regulations Title 21 CFR

820/814/210/211/11, ISO 13485, ISO 14971, Regulatory Compliance, and

Quality Control under an FDA/ISO regulated biomedical industries

V Expert in successfully implementing Design Control requirements

including Customer Requirements Specification(CRS), Design Requirement

Matrix (DRM), Design Input/Output, Design Verification/Validation,

Process Design, Potential application/design/process Failure Modes and

Effects Analysis (FMEA),Test Methods (TM), Test Method Validations

(TMV), Drawings and Material Specifications, Instructions for use of

medical devices (IFU), Design History File (DHF) deliverables, Design

Transfer, Manufacturing, Device History Record (DHR) auditing, Device

Master Record (DMR) process flow diagram, and continuous improvement of

the quality of process outputs

V Knowledge of statistical methods (z-test, t-test, F-test, ANOVA, chi-

square, Regression Analysis, Gage R&R,

statistical process control-SPC,

process capability-Cp/process capability index-Cpk, kappa statistic,

etc.) to evaluate test data, processes and measurement systems

V Administrating manufacturing efficiency improvement projects,

preparation of project timelines, deliverables, efficiently performing

tasks related to production quality control to consistently comply with

FDA/ISO regulations and cost effective implementation of regulatory

compliance

V Gap Analysis of existing manufacturing equipments, computer

hardware/software systems, process control documents, troubleshooting

guides, retest guides, and rework procedures for compliance with

regulatory requirements and cGMP

V Proficient in Validation of Computer Systems -CSV (IQ, OQ, PQ),

processes, test methods, and equipment used for bio-medical research,

medical devices manufacturing, regulatory compliance, etc.

V Exceptional investigation/troubleshooting skill to diagnose any

challenging issue of Electro-Mechanical Instrument/complex PCB to a

component level

V Conducting design of experiments (DoE), test and troubleshooting, root

cause analysis, and investigations

V Writing calibration and maintenance documents and configuring & setting

up mfg. equipments

V Writing incoming inspection documents, incoming material handling, and

dealing with vendors to resolve material issues

V Providing technical support/training to manufacturing group and direct

customers as well

V Excellent technical writing skills including writing process control

documents (PCDs), assembly instruction documents, material

specifications, test procedures, troubleshooting guides, retest guides,

rework procedures, flow charts, IFU, etc.

V Proficient in implementing the quality systems regulations

documentation (including: NCR, ER, CR, CAPA, ECN/ECR, PD, CMS, DCO,

etc.) for complying with FDA/ISO regulations

V Familiar with GD&T, ASME/ANSI 14.5 standards, Tolerance Analysis

V Excellent knowledge of computer hardware, peripherals, software

(SolidWorks, AutoCAD, Minitab, MS-Office suite, photo editors, Adobe

suite, web developing, etc.), programming languages (8086/8085 Assembly,

Oracle, PL/SQL, MS-Visual Basic 5.0, etc.), different precision

measuring/testing/programming/mfg. equipments (In-circuit test station,

DSO, CRO, digital/analog multimeter, EPROM programmer, function

generator, soldering/disordering station, digital microscope, digital

caliper, digital micrometer, etc.), ultrasonic welding, etc.

V Knowledge of Six Sigma business management strategy to improve the

quality of process outputs and Lean Manufacturing practice for steady

elimination of waste

EDUCATION & TRAINING

* Trained on Human Anatomy & Physiology by Dr. George W. Mulheron

* Trained on Human Anatomy & Physiology Cadaver Lab and Didactic by Dr.

George W. Mulheron

* Trained on Applied Statistics & Statistical Process Control

* Trained on FDA regulations Title 21 CFR 820/814/210/211/11, ISO

13485:2003, and ISO 14971

* Mastering Visual Basic 5.0 (Microsoft Certified Course), NIIT, India

* Diploma in Software Engineering (Sem. IV-RDBMS with Oracle), Aptech

Computer Education, India

* Bachelor of Science, Electronics & Communication Engineering (GPA:

3.16), University of Mysore, India

PROFESSIONAL Experience:

Business Partner (started new construction business)

2012-Present

. Prepared a preliminary business case and justification for the project,

performing market research, consulting local planning authority,

risk/reward calculations in worst case scenario, budget planning,

exploring various funding options, feasibility study, project execution

planning and implementation

. Taken some time off from work and traveled internationally, taken care

of my sick parent and set them up with a care giver

. Brushed up on my Biomedical Engineering knowledge and skills including

FDA/ISO regulations, Design Controls, Document Change Control (DCC),

QSR, GMP, statistical process control (Cp, Cpk, Control charts, etc.),

pFMEA/dFMEA, process control plan, Six Sigma (Define, Measure, Analyze,

Improve, Control), master validation plan (MVP),

validation/verification, computer system validation (CSV, IQ/OQ/PQ),

applied statistics (descriptive/inferential), Various parametric tests

of significance (z-test, t-test, F-test, ANOVA, chi-square, etc.),

regression testing, etc.

. Also, refreshed my skill with the latest Minitab 17, SolidWorks 2014,

Adobe Acrobat XI pro, and MS Office 2013 software

R&D Mechanical Engineer III (Ethicon, Inc., a J&J Company, NJ)

2010- 2011

. Authored various Design Control deliverables including IFU, TM, TMV,

Clinical Build Flowchart & Plan, Research Stability Study Protocol,

SolidWorks Drawing, Illustration, Summary Report, Attending various

Cadaver Labs & preparing Reports, etc. for new medical device research &

development

. Conducted Research Stability Study, writing test protocols, managing

numerous test samples for packaging/labeling/sterilization/stability,

testing, collecting and preparing consolidated test data report,

performing statistical analysis on test data, etc.

. Prepared Design Change History Report for FDA submission

. Managed project spending & tracking, accruals, POs, year-end/carry

forward financial tracking, etc.

. Setting up ultrasonic welding equipment and parameters, conducting DoE,

analyzing peak tensile strength, applying different statistical methods

to evaluate test data, processes & measurement systems, analyzing

knitting characteristics of absorbable/non-absorbable polymer mesh

implants, reviewing various drawings and documentations, tolerance

analysis, etc.

. Developed various device prototypes & samples, ordering appropriate

primary packaging/sterilization/secondary packaging and completing

required GLP study forms/traceability documentations for

biocompatibility testing submissions

. Efficiently completed routine tasks including writing meeting minutes

for weekly project meetings/technical reviews/design reviews, completing

various action items, preparing different presentations, updating patent

documents, preparing product components & assembly report letter,

packaging/labeling/shipping and handling of various product

samples/materials that are not for human use/not for sale, lab works,

etc.

Manufacturing Engineer (Abbott Point of Care, Inc. NJ)

2006- 2010

. Administered various manufacturing process improvement projects to boost

productivity, quality, and profitability

. Authored various process control documents, SOPs, assembly instruction

documents, material specifications, incoming inspection documents, test

methods, equipment calibration and maintenance documents,

troubleshooting guides, retest guides, and rework procedures used for

manufacturing of the medical equipments

. Performed functions associated with all manufacturing operation,

calibration/ testing/ troubleshooting & diagnosing of circuit boards and

electromechanical assemblies to a component level, reworks, and

documented failures/findings/root cause analysis/investigation summary

. Audited device history records (DHR)/device master record (DMR) for

accuracy and compliance

. Worked on various exception reports(ER), correction plans (CR),

corrective action preventive actions (CAPA) plans, process deviations

(PD), engineering change notice/report (ECN/ECR), and document change

orders (DCO) to continuously improve the quality of the medical products

. Conducted many experiments and investigations to pin point the root

cause of failures and failure analysis

. Authored computer system validation (CSV) master plan, efficiently

administered the entire manufacturing floor computer system

replacement/upgrade project, conducted project meetings, coordinated

with quality assurance department/IT department/production manager,

supervised and trained production personnel and successfully completed

the Validation of all manufacturing floor workstation PC based

configurations

. Administered, authored execution plan & protocol and successfully

implemented manufacturing floor workstation PC move project. After the

implementation there was not a single incident of any issue that created

an exception report/nonconformity.

. Provided technical support and training to the production personnel

. Consistently complied with FDA/cGMP/ISO Quality Systems Regulation (QSR)

requirements

Various Engineering Positions Held (at Solectron, CSR, etc. Companies in

USA) 1998-2005

. Authored various process control documents/guides, Quality control

procedures, Flow charts, troubleshooting electromechanical

assemblies/PCBs to the component level, in circuit testing,

experimenting, Supervising, training, etc.

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