Namitha Natasekhar

Senior Manager, Manufacturing Engineering at Nevro
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
San Francisco Bay Area
Languages
  • English Full professional proficiency
  • Hindi Full professional proficiency
  • Kannada Full professional proficiency

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

5.0

/5.0
/ Based on 2 ratings
  • (2)
  • (0)
  • (0)
  • (0)
  • (0)

Filter reviews by:

Dawnel Scott

Namitha is a very talented engineer and is an absolute pleasure to work with. She establishes strong relationships with individuals, both internal and external. She is quick to understand manufacturing and quality processes and is able to identify and offer well thought out resolutions to issues. Great attention to detail with excellent verbal and written communication skills.

Seth Masek

Namitha is a gifted individual both technically and personally. I worked with her on a critical project where she was able to coordinate resources to complete two weeks of R&D testing in three days. She worked long hours and managed several technicians and engineers while we executed a large scale product qualification protocol. Namitha also provided support on complex and advanced data analysis where her critical thinking and analytic capabilities were on display. More than anything, Namitha is a joy to work with. She is optimistic, enthusiastic and an aggressive problem solver. I would jump at the opportunity to work with her again, and I strongly recommend her to anyone looking for a reliable, hard working and technically savvy team member. - Seth Masek

You need to have a working account to view this content.
You need to have a working account to view this content.

Credentials

  • Certified Manager of Quality/ Organizational Excellence
    American Society for Quality
    Jan, 2018
    - Nov, 2024
  • The Science of Sterilization Validation Seminar
    Nelson Laboratories, LLC
    Nov, 2016
    - Nov, 2024
  • Lead Auditor
    AQS, inc.
    Jan, 2010
    - Nov, 2024
  • Certified Six Sigma Black Belt
    American Society for Quality

Experience

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Senior Manager, Manufacturing Engineering
      • Jun 2022 - Present

    • Manager,Manufacturing Engineering
      • Sep 2020 - Jun 2022

      Managing a team of MEs, leading sustaining projects and supporting NPI into production.Managed cross functional activities and High impact projects for Class 3 Active Implantables Overseas Product Transfer and production live - Costa Rica and Dominican RepublicNew product introduction- Development phase to production phase.Managed several CMs globally and ensure smooth supply chain.Engineering Lead on process implementation/validations/ submissions to FDA/BSI.Turnkey engineering support from process development, implementation, Bio compatibility, Sterilization and Packaging. Show less

    • Principal Manufacturing Engineer
      • Oct 2018 - Sep 2020

      Project lead International product transferAlternate supplier qualification and validation New product introduction

    • Senior Quality Engineer
      • Dec 2014 - Oct 2018

      Lead and implemented New site CER Commissioning and Implementation of the Automated pressure monitoring system. Lead multiple areas during the FDA Inspection. Lead multiple validations during the facility move. Lead Sterilization re-qualification, 3X Residual testing and other Sterilization projects. Lead supplier changes and issues concerning product manufacturing. Audited Suppliers Supported various areas of In-house Audits. Implemented automated data capturing system in the CER and Quality. Lead process NCMRs and CAPAs. QA lead engineering support for In-house Manufacturing of the Class 3 implants. Wrote validations for PMA approval of M6 C Show less

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Senior Quality Engineer
      • Feb 2014 - Dec 2014

      Performed Process/Equipment Validations Supported in product transfers to the new supplier sites. Managed Product quality & Calibration activities. Performed Supplier and Internal Audits. Performed production releases. Performed Process/Equipment Validations Supported in product transfers to the new supplier sites. Managed Product quality & Calibration activities. Performed Supplier and Internal Audits. Performed production releases.

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Principal Manufacturing Engineer/Operations Engg Lead
      • Jul 2013 - Feb 2014

      •Lead Operations on all product transfers to the other Covidien and Contract Manufacturing sites.Lead Operations Engg activities.Maintained high yields on all production lines (above 98%).

    • Senior Manufacturing Engineer/Operations Engg Lead
      • Apr 2012 - Jun 2013

      •Lead Operations on all Product transfers to the other Covidien sites and Contract Manufacturing.•Managed Operations Engineering with two direct reports Lead multiple areas during the FDA,ANVISA, TUV Audits•Worked on Product development from Design through Production.•Lead Engineering production support for all 3 production lines: Trellis (Balloon Catheter), RFS2 Catheter (RF Energy based device) and ClosureFast Catheter(Venous Insufficiency).•Lead Validation activities- Label Printer, EFD Validation, CLF line Validation and Packaging Validation.•Performed RCA, CA/PA on NMR’s ,CAPA’s and Internal Audit response relating to the production issues.•Lead Kaizen, delivered results on multiple cost saving projects.•Improved First Pass yield on the Trellis line from 90% to 97%.•Maintained consistent First Pass yield over 99% on Catheter(RFS2 Production line).•Worked with cross functional teams such as R&D, AME on fixing re-design,develop Poke-Yoke fixtures. •Performed multiple design verification tests. Show less

    • Manufacturing Engineer
      • Dec 2010 - Apr 2012

      Process Improvement Process Validation(IQ,OQ,PQ)Root cause Analysis Resolving NMR'sImplementing Corrective and Preventative Actions (CAPA's)Technical support resolving production issuesCost Optimization

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Senior Manufacturing Engineer
      • Dec 2009 - Dec 2010

      Conducting Supplier Audits as a Process expert Process Validation(IQ,OQ-E,OQ-P,PQ) on various production lines Validation Remediation for process bottle necks Certified Six Sigma Black Belt from ASQ Certified Lead Auditor ISO13485 Conducting Supplier Audits as a Process expert Process Validation(IQ,OQ-E,OQ-P,PQ) on various production lines Validation Remediation for process bottle necks Certified Six Sigma Black Belt from ASQ Certified Lead Auditor ISO13485

    • United States
    • Retail Apparel and Fashion
    • 700 & Above Employee
    • Industrial Engineer
      • Jun 2008 - Dec 2009

      Process Improvement projects on reducing cycle time Cost Reduction Facility Expansion project Strategic Analysis Process Improvement projects on reducing cycle time Cost Reduction Facility Expansion project Strategic Analysis

    • United States
    • Software Development
    • 700 & Above Employee
    • Industrial Engineer
      • Jan 2007 - Feb 2008

      Cost Optimization Managing acquisition/merger projects Software Black Box testing Data Mining Automation of mail sorting Cost Optimization Managing acquisition/merger projects Software Black Box testing Data Mining Automation of mail sorting

    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Intern
      • Sep 2006 - Dec 2006

      Cost optimization- Reduction of raw material scrap by 40%. Implemented an OR model for optimizing the Lycra material usage in manufacturing of knee braces for 3M. Developed and Implemented Inventory Management Model - classified A,B,C class items. Cost optimization- Reduction of raw material scrap by 40%. Implemented an OR model for optimizing the Lycra material usage in manufacturing of knee braces for 3M. Developed and Implemented Inventory Management Model - classified A,B,C class items.

    • Intern
      • Feb 2006 - Aug 2006

      Implementing Inventory Models Cost Optimization -WIP reduction Layout changes New Product line Introduction Implementing Inventory Models Cost Optimization -WIP reduction Layout changes New Product line Introduction

Education

  • State University of New York College at Buffalo
    Master of Science - MS, Operations Research
  • Siddaganga Institute of Technology
    Bachelor of Engineering - BE, Industrial Engineering

Community

You need to have a working account to view this content. Click here to join now