Engineer Quality

Pratikkumar Patel

■ Phone No: +1-618-***-****■ Email: ******.*************@*****.***

Qualifications Summary

●4 years of experience as a Validation Engineer and Quality Engineer with expertise in Test Method Validation, Design Verification Strategy and FDA Design Control guidance.

●Experience in Design History File (DHF) remediation, Process Validation, and New Product Development.

●Experience with FDA, ISO and other regulatory standards related to medical devices.

●Strong experience in Test Method Validation (TMV) of medical devices.

●Strong Experience with IQ, OQ, PQ, SOPs, Protocol, Gap Analysis etc.

●Expertise in CAPA (Corrective Action Preventive Action) lifecycle from initiation to closure.

●Execute and refer for closure CAPA investigations and action items; perform effectiveness checks when warranted.

●Created and updated existing DFMEA and PFMEA to perform required risk assessments.

●Knowledge and Hands on experience in Lean Manufacturing and Six Sigma Concepts (DMAIC).

●Skilled in problem analyzing techniques using statistical tools such as Minitab.

●Experience with Root Cause Analysis tools, DMAIC, 5 Whys, etc.

●Experience in working with Class I, II, III products.

●Experience with Device Master Record (DMR), MTF.

●Experience working in a manufacturing environment and applied lean methods to improve the process.

●Experience in Geometric Dimensioning & Tolerances (GD&T).

●Experience in SolidWorks, AutoCAD, MATLAB, and ANSYS.

●Strong understanding of different Cleaning Validation Techniques.

●Proficient in MS Excel and other MS office tools, MS Access.

Skill Set

●TMV, DHF, Gap Analysis, IQ, OQ, PQ, CC, CAPA, DFMEA, PFMEA, Lean/Six Sigma, DOE, NCR, Minitab, MVP, BOM, Gage R&R, Root Cause Analysis, 5 Whys, TQM.

●ISO, FDA, 21 CFR Part 820.30, 21 CFR Part 820

●Solid works, AutoCAD, ANSYS.

●MS Office Suite, MS Access.

Education

Masters of Engineering in Mechanical Engineering at University of Texas at Arlington, Texas.

Bachelors of Technology in Mechanical Engineering at K.K. Wagh Institute of Engineering Education and Research, India

Six Sigma Green Belt Certification, Management and Strategy Institute

Professional Experience

B Braun, Irvine, CA (May 2016- Present)

Sr. Product Development Engineer

●Performed feasibility analysis with several vendors to identify suitable commodities for a pre-filled syringe (plunger stopper, push rods, safety devices, etc.).

●Co-ordinated engineering testing on product samples to evaluate the options in the concept phase.

●Authored engineering Test Protocols, Reports etc. for feasibility testing.

●Reviewed and approved vendor Testing Protocols.

●Authored stability plan documents for various stability testing requirements needed.

●Worked with systems engineer for the creation of user requirement specification & performance requirement specifications.

●Authored design verification plan for the product family per Internal Quality Guidelines.

●Conducted test method validation on the test methods, which were to be used for Design Verification.

●Worked with design team to create the Test Method Validation (TMV) fixtures and test fixtures needed.

●Owned the transfer of critical design transfer of several test methods to the manufacturing locations to facilitate Incoming, In-process and Final release testing.

●Performed Gap Analysis and investigation for Nonconformance materials.

●Reviewed and approved Non-Conforming Report (NCR), assured that correct parts were made on schedule.

●Experienced with the Gage R&R and APQP (Advanced Product Quality Planning).

●Prepared design history files (DHF) in support of FDA including Design Inputs and Outputs, Design Reviews, Design Transfers and Design Changes.

●Review and Document the DHF Deliverables such as D&D plan, Verification & Validation (V&V) plan and Change Control (CC).

●Remediated Design History Files (DHF) for currently marketed medical device products to ensure compliance with ISO 10993.

●Performed extensive DOE using Minitab and analyzed the data using Minitab for the proper conclusion of the tests.

●Updated and created Risk Management documents using tools such as DFMEA.

Hindustan Medical Device Ltd., Faridabad, India (May 2013- July 2015)

Quality Engineer

●Successfully supervised engineering changes associated with tooling, modeling, and planning.

●Analyzed the quality assurance system and made recommendations for improvements. These were incorporated into the current quality assurance system.

●Applied lean and six sigma methods to improve the process.

●Authored Test Protocols and performed Test Method Validations (TMV) for mechanical devices.

●Knowledgeable in manufacturing processes from initial stages to final packaging products.

●Assisted with Installation(IQ), Operational (OQ), and Performance (PQ) Qualifications data.

●Deployed a DFMEA, PFMEA, FMECA methods worldwide, developed training materials and trained personnel.

●Involved in new product development activities such as creating prototypes and selecting appropriate measuring gages.

●Hands on experience on remediation projects to update the inspection sheets, routers, and drawings.

●Experience in the closure on nonconformance reports by taking corrective and preventive actions.

●Developed programs and methods to optimize production capability and reduce cycle time, improving manufacturing efficiency, and overall productivity

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