Shivakumar Bhaskaran
San Mateo
Summary
Results-driven technical professional, ASQ Certified Lean Six Sigma Black Belt and PMI-PMP with expertise working in the medical device industry for 8.5 years in the areas of Manufacturing, Quality Control, Validation activities, Risk management, Process Development, Project Management (Agile/Waterfall), Continuous Process Improvement in adherence to FDA regulation 21CFR part 820 and ISO 13485 & ISO 14971
Specialties: Process Validation, Test Method Validation, Gage R&R, Process Capability Analysis, Hypothesis Testing, Correlation& Regression analysis, DOE, PFMEA, SPC, Minitab, Closing Non-conformance report, Root cause analyses, Solidworks, GD&T (ASME Y14.5-2009), Lean Six Sigma methodology, Class III Medical devices.
Overview
10
10
years of professional experience
Work History
Sr. Process Engineer (Lead)
Medtronic
Menlo Park
11.2020 - Current
- Working on process that involves Stent (Material type: Polymer and fiber) forming, Annealing, Quenching, Bonding, Spray Coating, Delivery system assembly and packaging to treat chronic sinusitis.
- Provided technical support to determine visual inspection error rate that occurred during packaging preparation by determining Type-1 (α) & Type -II (β) error, confidence level (1-alpha) and Power of test (1-Beta) and concluded that the machine vision inspection system can inspect components and display appropriate accept and reject units without giving false signal of detection.
- Led a CAPA with a team of three as part of practice versus procedure resulting in the clarification of manufacturing instruction for error proofing/ NC reduction.
- Led process improvement project with a team of 6 in reducing production Line Clearance verification time from 7 hours to 4.15 hours, therefore resulting in cost saving of $720,000 (Phase-1) & $674,152 (Phase-2) and summarized the project in A3 report.
- Conducted T-test to check the Fiber Test data on Instron equipment’s and concluded statistical difference by rejecting Null Hypothesis. Worked with team to determine root cause.
- Created high level VSM of current state manufacturing process to determine Bottle neck in processes (Delivery system & Lot prep. area) and determine operation capacity (Includes Labor & Equipment) to increase production volume from 13k to 16.5k units on monthly basis.
- Increased product lot prep UPLH to 40% and found efficiencies to absorb the additional overlabeling work content within existing lot prep team without adding DL.
Process Engineer
Memry Corporation
Menlo Park
05.2018 - 10.2020
- Worked with Customers, Manufacturing, Quality and R&D to develop process to produce Nitinol Stent tubes per ASTM F2063.
- Performed validation activity (IQ, OQ & PQ) to qualify equipment’s and process used in the production.
- Conducted ATMV for O.D, I.D, surface defects based on AQL been recorded in Inspection Test Master and 100% visual inspection on Wall thickness and length.
- Applied statistical methods: a) DOE (fractional factorial) for process characterization on new centerless grinding machine to determine optimal settings, b) Process capability to check for Normality using 6 pack analysis and interpreted results on CpK, P-value, control chart and Histogram for O.D & Wall Thickness and c) Paired T test to compare the O.D of Nitinol material and concluded statistical significant using P- value by analyzing Probability plot, Individual value plot, Histogram and determined recommended settings.
- Conducted Destructive testing (Tensile Test) to check the mechanical properties (UTS, Loading plateau, Elongation, permanent set & Af) of Nitinol Stent tubes.
- Generated Process Flow map to utilize results of Tube Drawing process and improved Concentricity of tubes measured using Ultrasonic Gage from 80% to 95%.
- Improved First Pass Yield of Nitinol tubes by 35%, by: a) Mathematical calculation to determine raw material needing, b) Design process with draw sequence, c) Capture loss of material in each process (by Root Cause Analysis) and Implement control plan.
- Utilized OEE to determine the percentage of manufacturing time that is truly productive to monitor process, installed ANDON lights as visual control and improved equipment efficiency from 56% to 75%.
- Integrated with production to improve process Lead Time from 8weeks to 6.5 weeks by Demand Flow Technology.
- Performed Time study on manual San Blast operation, split lot from manual to Automated Wire Sand Blasting and reduced process time on an average of 20 minutes.
Manufacturing Engineer
Boston Scientific
San Jose
11.2016 - 05.2018
- Ensured functionality of the system by executing with an approved IVOT (Installation verification/Operational Testing) protocol and summarized the Qualification report after transferring the system from Fremont to San Jose per 21CFR 820.75, 820.70 & 820.72.
- Set up Production and Repair operation lines for new product, Qualified system, created BOM, Router, Work instruction and control plan.
- Troubleshoot issues on Pneumatic flow test fixture used in the system for testing Rotational Atherectomy (Electro-Mechanical device).
- Used Minitab 17 to perform 'Equivalency study' to compare the data of two identical flow fixtures and concluded Statistical significance using P-value >0.05.
- Created and routed documents such as Protocol, CAD drawings and PCAF in Windchill.
- Designed Enclosures as part of EH&S for laser operation and saved cost of $12,500 from installing interlock systems.
- Led and ensured conformance to Equipment & Automated System procedure for 5 laser operation lines.
- Initiated and involved in documentation of deliverables such as Qualification Plan (QP), User Requirement specification (URS), Functional Specification (FS), Installation Verification and Operational testing (IV/OT), Equipment Hazard Analysis (EHA), Requirement Traceability Matrix (RTM) and Qualification Report (QR) for the development and qualification of equipment and automated system.
- Developed OQ/PQ protocol for CO2 laser processes and wrote Qualification report (QR) per 21 CFR 820.75.
- Conducted capability study to evaluate Diameter and Length of Silicon Quartz tube of fiber catheter per the acceptance criteria of Ppk from sampling plan for OQ/PQ run and interpreted Probability plot to check for goodness of fit test using P value.
- Conducted engineering studies for process characterization (Range finding experiment) to establish in-process control.
- Performed gap analysis and provided inputs on validation activities for processes that are not fully verified.
- Authorized and updated Master Validation Plan (MVP) to initiate qualification of equipment’s and processes and developed Master validation report (MVR) to document validation activities.
- Authorized and executed Attribute test method validation (ATMV) to distinguish between conformance and non-conformance part and wrote validation report.
- Determined sample size based on Risk index, LTPD, Confidence & Reliability % for validation by referring PFMEA & SOP.
Quality Engineer (Contractor)
Zimmer Biomet
West Palm Beach
11.2015 - 06.2016
- Initiated and closed nonconformance, drove root cause and corrective action for issues affecting performance per 21 CFR 820.90.
- Managed, evaluated, and dispositioned of company's product line MRB of non-conforming material.
- Used TipQA software to write NC report which includes problem statement, Evaluation, Risk assessment, preventive and containment controls, bounding assessment to identify similar issue reflected in any other job, lot or process, and Interim action and disposition.
- Determined scope of impacted product, nature of problem, performed risk assessment and eventually determined immediate corrective action.
- Reviewed PFMEA and manufacturing documents where appropriate to determine severity of risk and conducted investigations.
- Conducted Gage R&R study using Minitab to estimate how much total process variation is caused by Measurement System.
Education
M.S - Industrial Engineering
Texas A&M University
05.2015
B.E - Mechanical Engineering
Panimalar Engineering College
04.2012
Skills
- Process Validation
- Test Method Validation
- Gage R&R
- Process Capability Analysis
- Hypothesis Testing
- Correlation & Regression analysis
- DOE
- PFMEA
- SPC
- Minitab
- Closing Non-conformance report
- Root cause analyses
- Solidworks
- GD&T (ASME Y145-2009)
- Lean Six Sigma methodology
- Class III Medical devices
Training Certificate
- Six Sigma Black Belt, ASQ, 24241
- PMP, Project Management Institute, 3704470
- Six Sigma Green Belt, Management and Strategy Institute, 11831870
- ISO 9001:2015, SAE International, 31245
- ISO 13485:2016, SAE International, 31242
- Fundamentals of GD&T ASME Y14.5-2009, IACET 1003713
Summary Of Qualification
Results-driven technical professional, ASQ Certified Lean Six Sigma Black Belt and PMI-PMP with expertise working in the medical device industry for 8.5 years in the areas of Manufacturing, Quality Control, Validation activities, Risk management, Process Development, Project Management (Agile/Waterfall), Continuous Process Improvement in adherence to FDA regulation 21CFR part 820 and ISO 13485 & ISO 14971. Specialties: Process Validation, Test Method Validation, Gage R&R, Process Capability Analysis, Hypothesis Testing, Correlation & Regression analysis, DOE, PFMEA, SPC, Minitab, Closing Non-conformance report, Root cause analyses, Solidworks, GD&T (ASME Y14.5-2009), Lean Six Sigma methodology, Class III Medical devices.
Timeline
Sr. Process Engineer (Lead)
Medtronic
11.2020 - Current
Process Engineer
Memry Corporation
05.2018 - 10.2020
Manufacturing Engineer
Boston Scientific
11.2016 - 05.2018
Quality Engineer (Contractor)
Zimmer Biomet
11.2015 - 06.2016
M.S - Industrial Engineering
Texas A&M University
B.E - Mechanical Engineering
Panimalar Engineering College