Olivier Kagan

Boston, MA area • 401-***-**** • acou9l@r.postjobfree.com • www.linkedin.com/in/olivierkagan

Quality & Regulatory Professional

10+ years combined experience leading international R&D organizations designing medical device

software and participating in all aspects of Quality Management and Regulatory Affairs.

• Quality Management & Regulatory Affairs (QARA)

o ISO 13485 and ISO 9001 certification (QMS), ISO 14971 Risk Management

o FDA 21 CFR 820 (QSR), FDA inspections (QSIT), closure of 483s and Warning Letter

o Continuous process improvement (incl. DMAIC, PDCA), Change Management

o Audits, process nonconformance, CAPAs, Management Review (QMR)

o CE Marking (STED Class IIa Medical Device) & FDA 510(k) (Class II Medical Device)

• International Program & Project Management

• Software Engineering

o 21 CFR 820.30 Design Control, IEC 62304, AAMI TIR45, CMMI

o Agile methodologies (SCRUM, eXtreme Programming)

o Requirements Management, Architecture & Design, Technical Authoring

o Visual C++, C++, Java, XML, SQL, Eclipse, Solaris, Unix, Linux, Windows, Mac OS X

o Defect Management (TestTrack, TeamForge, JIRA)

o Configuration Management (SVN), Continuous Integration (Maven, Jenkins)

o Design Verification, Test automation (TestComplete, Junit, CppUnit, Perl) & Validation

• HealthCare Information Technology (HIT)

o DICOM, HL7, IHE, SNOMED CT, ICD, CPT, RxNorm

o CVIS, PACS, RIS, HIS, CIS, Radiology Diagnostic workstations, Telemedicine

• Knowledge Management (Communities of Practices, Wikis, Document control, Training)

• Languages: French (native), English (fluent), Spanish (conversational fluency)

Professional Experience

Global Business Process Manager - R&D Operations for Medical Software 2012 - 2015

AGFA Healthcare, Medical Imaging Solutions & Health Information Systems – Westerly, RI

Reporting to the director of Quality Assurance & Regulatory Affairs, ensured compliance of all

software engineering operations with applicable regulations and standards.

• Closed an FDA Warning Letter, FDA 483s, CAPAs, audit findings

• Led global process improvement programs for operations of 1,000+ R&D employees across

all R&D sites (USA, Canada, Germany, Austria, France, Belgium, and China)

• Key contributor to global process improvement programs impacting whole company (4,800+

employees)

• Established compliance with ISO 62366 (Usability Engineering)

• Established R&D compliance with ISO 27k (Information Security & Privacy)

• Led the redesign and roll out of the company’s tool validation process (100+ tools)

• Improved implementation of Agile practices by transitioning from multiple tools to JIRA Agile

• Led the Laboratory Information System (LIS) R&D team to compliance with ISO 13485

• Improved regional product launch process by simplifying knowledge transfer between

Engineering, Marketing, Sales, Legal, Services, and QARA

• Improved global process and system for Training Management

• Improved company’s QMS by defining the global Process Management procedure

• Designed and performed internal audits, supported resolution of nonconformance

• Invited by the global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade

Association (DITTA) to provide interactive training on ‘Design control for software as a

medical device’ to international regulators, IT companies, and researchers

Olivier Kagan (Page 2)

Director, R&D Software Engineering, Cardiovascular Business Unit 2010 - 2012

AGFA Healthcare, Medical Imaging Solutions & Health Information Systems – Westerly, RI

Reporting to the BU Manager, led the evolution of the company’s Cardiovascular Information

System (IMPAX CV):

• Led teams of product managers, architects, software developers, technical writers,

verification engineers and validation specialists (40+ staff - $7M budget)

• Conducted cultural and operational integration after company acquisition

• Oversaw the release of important service updates addressing risk to health (21 CFR 806)

• Grew and mentored QA team to efficiently identify quality issues

• Organized retro-analysis and completion of Design History File to support regulatory filing

Acted as Management Representative for the site (100+ employees)

• Participated to FDA inspections and created the response to FDA observations (483)

• Brought the R&D operations to FDA compliance

• Managed BU Management Reviews (QMR) and Corrective & Preventive Actions (CAPAs)

As part of global quality improvement program, led team of 15 experts and consultants to redesign

and roll out global Design Control procedures and instructions to all R&D sites (1,000+ employees).

R&D Site Manager – Austria & Italy 2008 - 2010

AGFA Healthcare, Medical Imaging Solutions & Health Information Systems – Vienna, Austria

• Managed all software engineering activities at Austrian and Italian R&D sites (70+ staff)

• Delivered frequent releases of successful products (IMPAX EE, ORBIS RIS, IMPAX Agility)

Matured and grew the Vienna R&D site into a strategic center of excellence:

• Conducted the cultural and operational integration after company acquisition

• Defined the operational environment (organization, processes, tools, metrics)

• Doubled R&D staff (hiring & training program)

• Guaranteed frequent defect-free releases by creating R&D dashboard including continuous

integration, static code analysis and test automation (5,000+ tests running continuously)

• Created and animated a global Community of Practices around Test Automation

Contributed to the development of our next generation solution (IMPAX Agility):

• Multi-site project management (100+ contributors across 5 sites and 3 continents)

• Implemented a Feature Release Process enabling continuous update of customer base

R&D Team Lead, Software Architect, R&D Engineer 2003 - 2008

AGFA Healthcare, Medical Imaging Solutions & Health Information Systems – Paris, France

Led the R&D team in charge of the IMPAX SE suite (PACS & diagnostic workstations):

• Expanded the team from 3 to 12 members (mentoring, coaching)

• Expanded from 3 products sold in France to 9 products sold in Europe and USA

• Created agile software development and release process compliant with ISO 13485

• Obtained CE marking and FDA clearance to market in the USA via 510(k) submission

• Optimized quality, productivity and on time delivery

• Supervised Architecture (Client/Server, SOA, plug-ins) and Design (UML, design patterns)

• Coordinated and actively contributed to development (Visual C++, XML, SQL)

• Established best practices around Refactoring, Peer Programming and Code Reviews

• Implemented a test automation strategy for the product’s critical components

• Organized testing with vendors, participated in IHE Connectathon in Barcelona

• Demonstrated our solutions during tradeshows (JFR-Paris / RSNA-Chicago)

Olivier Kagan (Page 3)

Services Project Manager 2003

AGFA Healthcare, Medical Imaging Solutions & Health Information Systems – Paris, France

Specialized in Procurement & Accounting module of French Hospital Information System (C.Page)

• Answered to Request for Proposals and demonstrated product to potential customers

• Led roll out at customer sites including user training, consulting and data migration

• Provided technical support (hotline and remote access)

Software Engineer 2002

Monterey Design Systems, Solutions for Electronic Design Automation (EDA) – Sunnyvale, CA

As member of a team of 15 engineers, improved the performance of algorithms for company's main

product: a software to design microprocessors.

• Detailed design (UML + design patterns), C++ development under Solaris

• Automated Testing in Verilog and Perl

Education

• Master’s Degree in Computer Science (Information Systems and Languages)

IFSIC, University of Rennes (France) – 2002

• Bachelor’s Degree in Mathematics and Computer Science

University of Rennes (France) - 1999

• High School Diploma (Science Baccalaureat), Rennes (France) - 1996

Trainings

• Weekly Cardiology and Medical Practices Training - 2010-2012

• Online courses from the Harvard School of Business - Since 2009

• AGFA HealthCare’s Global Leadership Program (25 participants out of 4,800+ employees) -

2009

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