Summary
Overview
Work History
Education
Skills
Visa
Timeline
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SAHANA NANJAPPA

SAHANA NANJAPPA

Valencia,USA

Summary

5+ years of Engineering Experience within Medical Device Industry (Boston Scientific Neuromodulation). Proficient in ISO 13485 Quality Management Systems, with a strong focus on risk management (ISO 14971), design controls, and ensuring compliance with regulatory standards. Skilled in conducting Root Cause Analysis, Failure Mode and Effects Analysis (FMEA), and implementing Corrective and Preventive Actions (CAPAs) to drive continuous improvement. Demonstrated ability to collaborate effectively in cross-functional teams, ensuring the development of safe, reliable, and innovative implantable and electromechanical medical devices.

Overview

14
14
years of professional experience

Work History

Family Sabbatical

Santa Clarita
02.2018 - Current
  • Took a deliberate and planned break from professional pursuits to focus on caregiving for my children
  • This period not only strengthened my commitment to family but also honed my organizational prowess and multitasking abilities.

Manufacturing Engineer II

Boston Scientific Neuromodulation
Valencia, CA
01.2013 - 02.2018
  • Collaborated closely with expansive cross-functional teams, including Regulatory, Design Quality Assurance, Quality Engineering, Process Development, R&D, and Product Management, within ISO 13485 Quality Management Systems.
  • Served as Mechanical Engineering Lead for several Leads, Surgical Tools, Externals, and Electronics Sustaining projects, focusing on design quality assurance and design controls.
  • Supported generation of Risk Management Plans, Hazard Analysis, FMEAs, Risk Management Report, per ISO 14971 standards to ensure comprehensive risk assessment and mitigation strategies.
  • Provided Line support, facilitated BoM updates, and managed CAPAs, with a keen focus on maintaining compliance with regulatory standards and internal quality requirements.
  • Conducted Root Cause analysis and addressed non-conformances, including Material Review Board (MRB) disposition, leveraging expertise in design controls and risk management principles.
  • Submitted Engineering Change Orders (ECOs) to drive necessary modifications and improvements, while ensuring adherence to design quality assurance protocols.
  • Successfully led the commercialization of Boston Scientific's Infinion-CX Spinal Cord Stimulation (SCS) Lead and ENTRADA Introducer Needle, emphasizing design quality assurance throughout the New Product Development (NPD) process, including Manufacturing Readiness Reviews and release of Manufacturing Acceptance Plans and Reports.

Manufacturing Engineering Intern

L.L. Bean, Inc.
ME
07.2010 - 12.2010
  • Investigated and supported root-cause analysis for the legendary L.L
  • Bean boot bottom molding process
  • Assisted manufacturing team with implementing lean manufacturing principles for cost savings.

Education

M.S. - Plastics Engineering

University Of Massachusetts
12.2010

B.S. - Polymer Science and Technology

University of Mysore
05.2003

Skills

  • QMS (ISO 13485)
  • Risk Management (ISO 14971)
  • CAPAs/NCEPs
  • Manufacturing Processes
  • Process Improvement
  • MS Office Suite (Word, Excel, PowerPoint)
  • Project Planning

Visa

Work Authorization/Visa not required. Authorized to work for any employer in the USA.

Timeline

Family Sabbatical

02.2018 - Current

Manufacturing Engineer II

Boston Scientific Neuromodulation
01.2013 - 02.2018

Manufacturing Engineering Intern

L.L. Bean, Inc.
07.2010 - 12.2010

M.S. - Plastics Engineering

University Of Massachusetts

B.S. - Polymer Science and Technology

University of Mysore

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SAHANA NANJAPPA