ANKIT BHATIA Contact No.: +91-990*******

E-Mail: ac4mwh@r.postjobfree.com

Experience Summary:

5+ years of diverse Medical domain exp. in Q&R, US FDA, ISO 13485, Risk Management, DHF & Technical file submissions, Lean tools, Complaints handling, CAPA and Regulatory reporting. Currently leading the Complaint Handling team for Mobile Surgery C-arm and Cathlab systems at Philips Healthcare Innovation Campus.

Experience Highlights:

Expertise in product Risk management as per ISO 14971, DFMEA, Hazard Analysis, Usability and Clinical harms, Design and Clinical Risk Management.

Worked for various product lines including C-arms, Cathlab, Orthopedic, Spinal, Craniomaxillofacial, Urological, In-Vitro Fertilization and Drug delivery devices.

Comprehensive knowledge and experience in Design controls implementation, 21 CFR 820.30.

Experience with New Product Development Process, concept design, design calculations. Biodesign Process for Class I & II devices.

Management of TrackWise system for Complaints and CAPAs; Complaints, Trend code analysis and reports for QBR, Risk profiling – Product-wise Risk Summaries.

CAPA investigations, reviews and subsequent risk management documentation updates.

Performed Root Cause Analysis, PRIDE methodology, 8-D Problem solving, 5WHY, Fish Bone diagram to resolve complex issues.

Creation of Design History Files (DHFs) and Technical Files for FDA and EU submissions for new and legacy products.

Quality Assurance based on ISO, EN, BSI, ASTM and JIST standards.

Ensuring compliance with SOPs, Quality and Regulatory standards; Standards assessment.

Responsible for identification of non-conformities based on the analysis of Design inputs & outputs and Verification & Validation documents. Participated in design reviews to evaluate design.

Experience in Medical Quality Management System ISO 13485, 21 CFR Part 820, MDD 93/42/EEC.

Experience in Complaints analysis, Post market surveillance and Reliability Analysis, CE Marking, UDI. Knowledge of FDA coding systems and MAUDE database.

Process improvements, Value Stream Mapping (VSM), Lean tools.

Created and reviewed different elements of DHFs including User needs, Design Traceability Table, Risk Management report, DFMEA, Hazard analysis, Design Outputs redlines and updates.

Involved in Project Quality Assurance activities and audits. Framed checklists and work instructions for various deliverables. SME for Complaints handling activities in audits: ANVISA, ISO 13485: 2016, DEKRA, MDSAP and KGMP.

Supported in Protocol and Report creation for Mechanical Verification tests, Benchmarking tests, Characterization tests. Created Engineering rationale reports to supplement design verification. Assisted in creation of Master Verification plans and Test Evaluation Matrix.

Experience in creation of Clinical Validation reports, Opinion forms for validation of user needs.

Experience of working across various PLMs such as Windchill, Agile, SAP, JDE, JBase etc.

Sound Knowledge on Biocompatibility, Sterilization, Packaging and Labeling requirements.

Responsible for Clinical domain and Risk management trainings to the team. Education:

Program Institution % / C G P A Y e a r

M.Tech Clinical Engg. IIT Madras, CMC Vellore, SCTIMST 8.8 2012 B.E Biotechnology UIET, Panjab University, Chandigarh 7 2010 XIIth S.G.G.S.C.P.S Chandigarh 73 2005

Xth Hansraj Public School, Panchkula 90.2 2003

Professional Experience:

Philips India Ltd. (Healthcare Innovation Campus) Sep 2016 – Current Complaint Investigator (Q&R- CHU)

HCL Technologies Ltd. July 2013 – Aug 2016

Lead Engineer

Stanford India BioDesign, AIIMS - IIT Delhi May 2013 – July 2013 Research Intern

IFGL Bioceramics Ltd. Dec 2012 – May 2013

Business Development Manager

Academic Projects:

Development, Characterization & Evaluation of Novel Nano-HAP based products for Dental Enamel Remodeling SCTIMST, Trivandrum. (June-Dec 2012)

Techniques used - Vicker’s Hardness Test, Scanning Electron Microscopy, Atomic Force Microscopy and Surface Roughness Test, Statistical tool ANNOVA.

Developed a concept for Early Caries Diagnosis Device using Impedance measurement.

Development of a novel device for hypothermic treatment of neonates at CMC Vellore. Project was aimed at development of an indigenous & cost effective product for hypothermic treatment of Asphyxia affected neonates. Developed an electro-mechanical device prototype based on thermoelectric effect to act as a heat sink. June 2011 – July 2011

Drug Designing (Bioinformatics based) for targeting Tuberculosis at IBI Biosolutions Ltd. May 2009 – July 2009

Isolation, Characterization and Genetic Analysis of SLCV virus at Panjab University. Jan 2010 – April 2010

Internships:

Workshop on Material characterization & Packaging validation at UL India

Clinical Immersion along with OT visits at hospitals CMC Vellore and SCTIMST for 1.5 years

Industrial Exposure at HLL Lifecare Ltd. Trivandrum and Panacea Biotech Baddi

Clinical Engineering Internship at Fortis Hospital Mohali, Punjab. [1 month, Jan 12-Feb 12]

Internship at Biomedical Engineering Department, CMC Vellore. [3 months, Feb 11-April 11]

Attended International Clinical Engineering Workshop (ICEW) 2010 in Pune.

Industrial Training at Indswift Laboratories Ltd, Derabassi. [1 month, June 10-July 10] Technical skills:

Medical Device Development Lifecycle; Biodesign Process, Risk management, QMS.

21 CFR 820, ISO 13485, ISO 14971, Biocompatibility ISO 10993, IEC 60601, IEC 62353, ASTM stds.

MS Excel Advanced, Microsoft Power BI reports, Minitab.

Design software: Working knowledge on AUTOCAD, PRO ENGINEER, SOLIDWORKS, ANSYS.

Domain knowledge on Clinical Engineering, Anatomy, Physiology and Biomechanics.

Internal Certifications by HCL Tech. Ltd. in Medical devices QMS, Medical devices - Orthopedics, CAD Engineer Level-1, Design Engineer Level-1.

Basic training on GD&T, Tolerance Analysis and Statistics.

Certification for Computer Aided Drug Design from IBI Biosolutions.

Certificate course in Patient Safety facilitated by John Hopkins University. (Coursera based) Achievements:

Won the ‘Team of the year’ Award at Philips HIC Annual Event 2017.

Represented Philips HIC Globally at the Semi-Finals of the Philips Excellence Competition in Philippines, 2017.

Won the SPOT Award for exceptional performance in Philips, 2016.

Won SPOT Award twice at HCL Technologies Ltd.

Selected for the post of Entrepreneurship Development Officer at BIRAC, DBT.

Selected for Stanford India Biodesign Internship 2013 at AIIMS-IIT Delhi-Stanford University.

Filed a Patent for a Class 1 medical device.

Publication in Elsevier journal for Strontium doped n-HAP for Dental enamel remodeling.

Volunteered in a project for Urinary Incontinence treatment based on Nerve Stimulation at CMC Vellore.

Qualified GATE with AIR 290 (Percentile 99)

Personal details

D.O.B: 12th Oct 1987

Gender: Male

Marital Status: Married

Nationality: Indian

Languages Known: English, Hindi, Punjabi

Contact no.: +91-990*******

Email Id: ac4mwh@r.postjobfree.com

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