Karine Tadevosyan

About Karine Tadevosyan

Project Management, WPICQE certification ASQ 2013Design for LEAN, MDT Corporate, Danvers MA 2006Management Skills for New Managers WPI, MA 2005Dale Carnegie Effective Speaking and Communication Dale Carnegie Training, Boston, MA 2005Medtronic Technical Engineer MDT Corporate MA2004GMP Quality System Requirements and Industry Practice AAMI, Washington, DC 2003Specialties: Validation/Qualification per GMP and QSR, Lean and Six Sigma, DMAIC, VSM, Project

Experience

1. Principal Mfg Engineer Staff Engineer R & d Staff Engineer

   Abbott

   Jun 2016 — Present · Westford, MA, US

   Lead Ultreon software new hardware process validation / launch build activities through various program trackers, meetings, status updates. Worked under resource constraints and tight deadlines without available time buffer. In order to mitigate missing program deadlines for the PV milestones, was able to successfully be a stand-by resource to fill out any resource gaps (Mfg, Quality, Operations, etc) in addition to the project lead role. The tasks included but not limited to weekly status updates to senior management, daily standup meetings with core and extended team members, supporting all resources through communications and additional resource allocations when needed, creating/releasing MVR, building launch quantities on BAR, ZCBM / ZENG engineering work orders, tracking over 100 change orders, etc. As a result the major milestones in the program and launch build deadline for International geographies were met on time (New product launch)-Core team member on multiple next generation Opstar catheter launch. Contributions included but not limited to process development on adhesive joints, coating, tensile test methods, write up or contributions to protocols / reports write up for equipment and processes, DFMEA / PFMEAs, MVP / MVRs, manufacturing procedures and test methods, product spec requirements testing and data analysis, built at risk and engineering requests initiation / completion- Qualified new additional lines 3 - 6 for the new product ramp up to meet increased build plan. Had to fill in both leading and contributing roles, supporting and coaching new quality engineers on the project. In addition, supported a coating equipment qualification and process hooping rework qualification, closed out equipment nonconformance and GDP related exceptions and CAPAs- Have provided a support and mentoring to young engineers on leading and teaching on company SOPs and statistical techniques helping to push their projects forward.

Education

• Medtronic Headquarters

  Certificate, Lean / Six Sigma

  2003 — 2005

• Northeastern University

  MS, Doctoral Candidate (ABD), Industrial Engineering

  2000 — 2003

• American University of Armenia

  MS, Industrial Engineering

  1995 — 1997

• Indiana State University

  PhD-transferred to NEU, Technology Management

  1999 — 2000

• Yerevan State University

  BS, Mechanics and Applied Math

  1987 — 1992

• WPI

  Project Management, Certificate

  2005 — 2006

Skills

• Gmp
• Injection Molding
• Quality System
• Quality Systems
• V&V
• Green Belt
• Process Simulation
• Ms Project
• Design for Manufacturing
• Validation
• Iso 13485
• Minitab
• Medical Devices
• Capa
• Product Development
• Process Capability
• Management
• Fmea
• Qsr
• Project Management
• Design Control
• Dmaic
• Manufacturing Engineering
• Doe
• Six Sigma
• Gage R&R
• Value Stream Mapping
• Process Improvement
• Kaizen
• R&D
• 5s
• Software Documentation
• Root Cause Analysis
• Engineering
• Design of Experiments
• Manufacturing
• Lean Manufacturing
• Biomedical Engineering
• Testing
• Continuous Improvement