Debra Haehn

About Debra Haehn

Industrial Engineering and Quality Systems professional with 20+ years experience in the…

Experience

1. Global Systems Reliability Engineering Architect for Ct Advanced Molecular Imaging

   Philips

   Jan 2010 — Present · Highland Heights, OH, US

   Responsible for development, implementation and training for the Design for Reliability (DfR) Program for the Computed Tomography / Advanced Molecular Imaging business supporting sites in the US, China, Israel and India. Responsibilities include Process, Tools and Best Practices and facilitation of Training for hardware and software reliability activities and DfR activities for New Product Development. DfR activities include development of Reliability Plans that include Reliability Requirements, Reliability Allocation, Reliability Prediction, Operational Profiles, Design and Software FMEAs, Confirmation of design margin and / or development of accelerated tests to demonstrate required reliability.Lead team to implement IEC 62304:2006 Medical Device Software - Software Lifecycle ProcessesDeveloped process for conducting DFMEA/Software FMEAs, purchased and validated FMEA tools, facilitated training and multiple global System, Design and Software FMEAs.Developed Reliability Plans for multiple new global projects to address: Field Data Analysis, Reliability Requirements, Allocation and Prediction, Development of Operational Profile, FMEAs, Quantifying Design Margin and Development of Accelerated Test Plans, Identification of software reliability improvements. Lead a global team to develop and implement robust, compliant Corrective And Preventive Action (CAPA) process aligned with Risk Management, Complaint Handling and Purchasing Controls processes.Lead a global team to secure IEC60•••13rd edition certification for Nuclear Medicine product lines.Obtained Six Sigma Green Belt certification May 2012 for Service Call Coding Improvements and obtained Six Sigma Black Belt certification September 2012 for re-architecting the CAPA system.Sr. Member of and Working Group Secretary and Reviewer for 16••••16 Recommended Practice on Software Reliability, 18-Jan-2017

Education

• Cleveland State University

  Master of Science, Industrial Engineering

  2007 — 2009

Skills

• Fmea
• Project Management
• Reliability Engineering
• Process Engineering
• Fda Gmp
• Root Cause Analysis
• Iso 13485
• Value Stream Mapping
• Design Control
• Process Improvement
• Corrective and Preventive Action (Capa)
• Product Development
• Medical Devices
• Capa
• Lean Manufacturing
• 21 Cfr
• Engineering
• Spc
• 5s
• U.s. Food and Drug Administration (Fda)
• Process Capability
• Manufacturing
• Electronics
• Industrial Engineering
• Iso
• Business Process Improvement
• Fda
• Iso 14971
• Dmaic
• Manufacturing Engineering
• Leadership
• Product Design
• Product Launch
• Quality Assurance
• Quality System