Parth Patel

**** ***** **, ****** ** ***** 607-***-**** adhx0d@r.postjobfree.com

SUMMARY

Having extensive experience as Manufacturing engineer with highly professional attitude and proven track record of success in reducing operational cost, monitoring manufacturing processes, and maintaining high quality of products. Expertise in utilizing tools for investigation – 5 Why’s, Fish bone. Expertise in Geometric Dimensioning and Tolerances (GD&T), Production Metrics and Material Handling, Technical Writing, Validation Protocols, CAPA, Risk Management, Root Cause Analysis, Quality systems, Quality Assurance and Quality control. Well versed with DFEMA, PFMEA, APQP, Strategic Planning, Problem Solving and Process validations and process consistency.

SKILLS

Data Analysis and Simulation: MS Excel, Minitab, Solid works, Creo, SIMIO

Programming: R Programming, Python, Oracle

Technical skills: DelCAM, ProE, Fabrication, Plastic solid injection molding, Excel, Fusion 360, GD&T

Design and Manufacturing: Part modelling and product design, 3D printing, Stress and shear analysis, Complex CAD, Lean Quality tools (5S, Kaizen, and quality function deployment, fishbone diagram), Sheet metal design

Remediation includes: CAPA Resolution, Quality Systems (QSM) Review, Post market surveillance of medical devices, Quality Management Systems, Complaint Handling, Test Procedures, Risk Management Files (RMF)

PROFESSIONAL EXPERIENCE

Stryker, NJ August 2019 – Sept 2020

Manufacturing Engineer

Developed, created and reviewed documents for Process Validation (IQ, OQ, PQ), Master Validation Plans, Test Method Validation (Gage R&R), Process FMECA

Formulated Inspection Method and Test Method Validation (IMV/ TMV) Protocols and Reports

Assisted with investigation of Corrective/Preventive Actions (CAPA) and structures problem solving to determine root cause using fishbone diagram, 5Whys, etc.

Completed test method and process validations (TMVs) for new instrumentation, raw material properties and component qualifications

Investigated technical conflicts and provided engineering support to Manufacturing processes, SPC, and non-conforming material (NCR)

Drafted and reviewed Decision Trees (MDR & Investigations) for complaint handling

Ensured customer complaint investigation, procedures, and activities in strict accordance with applicable FDA and ISO requirements for complaint handling and adverse event reporting

Analyzed sub-assembly lines to develop design documentation including DFMEA, PFMEA for risk mitigation

Developed and wrote Design qualification plans and reports and executed the design verification plan

Designed, documented (using AutoCAD / SolidWorks) fixtures, jigs, tools, and gages

Maintained Requirement Traceability Matrix (RTM) to cross-reference functionality for required test cases and scripts

Conducted Risk Assessment, Risk Management plan, DFMEA, Hazard Analysis, and Risk Management reports specifically for efficiency and quality improvements

Applied quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, Cause & Effect Matrix, DOE, MSA and Control Plans

Supported remediation of Design History File that includes Customer Requirements, Product Requirements, System Level Requirements, Hazard Analysis, Design FMEA and Process FMEA

Applied knowledge of GD&T and tolerance stacking to ensure high precision gages meet design criteria

Lead technical improvement projects, conducted design of experiments (DOE) to identify critical variables in process

Successful maintained and updated Standard Operating Procedures (SOPs), Design History Files (DHF), cGMP’s and Design of Experiments (DOE)

Working on ISO 13485 / 21CFR820 (design control processes)/ ISO 14971 compliant environment

Managed low risk Nonconforming Product Reports (NCR's) per decisions made at the MRB meetings

Natco Pharma, India January 2016 - July 2018

Manufacturing Engineer

Participated in multiple product development activities including design reviews, development of FMEA, audits, specification reviews, product transfer to standard production, and selection / design of tools, gages and inspection tools, etc.

Minimized costs and resolved production problems by using DMAIC six sigma identified bottlenecks and implemented new tools

Achieved 10% reduction in cycle time and 15% decrease in material handling using Value Stream Mapping and Kaizen

Developed efficient layouts for workstations and distribution using Lean and 5S concepts

Performed inspections, and set quality assurance testing models for analysis of raw materials, materials in process, and finished products using FMEA and fish bone analysis Implement and expanded Lean Manufacturing, 5s, VSM etc.

Provided technical support to R&D, manufacturing engineering, regulatory affairs, supply chain, and quality to ensure conformance to component/product specifications.

Developed and maintained product documentation, including but not limited to product specifications, drawings, DFMEA, PFMEA, and control plans which improved and controlled the design and process of the parts produced

Reviewed and approved protocols and reports related to Packaging Tests (Bubble Test, Dye Penetration Test)

Performed Gap Analysis for the Design FMEA of product and Process FMEA of manufacturing process to ensure compliance to the end user’s specifications

Managed low risk Nonconforming Product Reports (NCR's) per the decisions made at the MRB meetings

Implemented disposition of discrepant material (MRB) managed recalls and devised methods to assess cost and responsibility

Created new Supplier Quality Metrics to identify and target poor performing suppliers and issued corrective actions

Utilized statistical methods, such as, process capability data analysis, statistical process control (SPC), sample size and frequency selection to ensure processes capability and repeatability

Was Responsible for supplier qualification and management of all suppliers across all programs

Conducted Risk Assessment, Risk Management plan, DFMEA, Hazard Analysis, and Risk Management reports

EDUCATION

Binghamton University, State University of New York, NY May 2020

Master of Science in Industrial and System Science Engineering

Gujarat Technological University, Gujarat, India May 2016

Bachelor of Mechanical Engineering

RELEVANT COURSEWORK

Electronics Manufacturing, Integrated Manufacturing, Quality and Process Improvement, Modeling and Simulation, Healthcare Finance, Supply Chain Management, Probability & Statistics, Enterprise Engineering

ACADEMIC PROJECTS

Ultrasonic vibration assisted Thermal manufacturing:

Introduced ultrasonic mechanism in thermal manufacturing process and demonstrated effect of vibration mechanism on microstructure, grain size, acoustic streaming and cavitation

Urban Traffic Modelling and Simulation:

Using SIMIO software, project team was able to come up with a new set traffic light duration setting with enhanced throughput of system while reducing Q-length of system

CERTIFICATION

Lean Six Sigma Green Belt certified from State University of New York at Binghamton

Engineering Ethics certified from State University of New York at Binghamton

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