BRUCE FIEGGEN
973.628.4597 (hm) · 973. 768.3831 (cell) · bruce@fieggen.com
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SUMMARY OF QUALIFICATIONS
Project Management Expert with extensive experience initiating and maintaining project management systems in the Life Sciences industries. Sets up Project Management Offices. Trains and mentors project managers to increase project efficiency and accelerate product time-to-market.
PROFESSIONAL EXPERIENCE
Q Pharma Corporation, Morristown
Vice President of Project Management and Training.
· Created recruiting arm of Q Pharma, developed systems to streamline recruiting process, resulting in a steady stream of excellent employees.
· Formalized training of in-house employees, ensuring that Q Pharma employees appeared at client site fully ready to take on the responsibilities required of them.
· Conducted public and on-site training courses for our customers, enhancing Q Pharma’s reputation as an experienced company.
· Trained hundreds of project managers, team members, their managers and executives in the CadenceTM project management methodology, decreasing time to market.
CSSC Inc., Morristown , NJ
Director of Project Management.
· Built Project Office, instituting methodologies, standards, metrics and policies and ensure adherence to procedures; achieving recognition for CSSC as a company that embraces project management.
· Developed formal ProgressixSM project management curriculum to improve project efficiencies. Train project managers and validation managers using this 25-week course.
· Trained validation engineers and scientists to use specific tools through a formal 3-day CadenceTM project management course, increasing their knowledge of project management complexities.
· Program manager for major pharmaceutical clients, overseeing nine project managers and twenty projects.
· Managed many new product development projects, bringing a complex idea to market through a combination of rigorous adherence to project management methodologies and excellent people-skills.
· Facilitated over 200 project kick-off / planning sessions, gaining clients’ support through their understanding of the complexities of each project and their roles within the projects.
· Sell CSSC services to clients, leveraging its leadership position in managing projects effectively.
Manager, Project Management
Set up and maintained Project Management systems that increased project efficiency; trained and mentored project managers.
· Customized two-day project management training course with outside vendor to address BSC-specific issues and meet Project Management Body of Knowledge standards.
· Developed, sold and achieved company approval of comprehensive project plans for $100M per year next generation aortic graft and endograft teams designed to increase market share.
· Led three teams designed to maintain $80M/year market share, maintaining contracts between teams and senior staff. Resolved Mad-cow disease issue with collagen-sealed grafts.
· Facilitated project prioritization sessions with company vice-presidents, ensuring every important project was fully resourced. Reduced active project list from 175 to 25.
· Wrote definitive, 80-page manual on using project management to efficiently design and market safe and effective medical devices. Included risk management and reimbursement.
Datascope Corporation, Fairfield , NJ
Senior Project Manager
Managed projects to improve core products with expected revenues above $100M per year.
· Wrote 120-page design control manual to help design medical devices in compliance with ISO and FDA regulations.
· Mentored five project managers in effective project management and ISO documentation, improving teamwork and reducing confusion.
· Led project team developing new membrane for intra-aortic balloon that reduced number one customer complaint ten-fold.
Project Manager
Managed projects to improve guide-wire lubrication.
· Managed project team that designed a lubricant for intra-coronary atherectomy device.
· Developed a coronary artery compatible lubricant that reduced guide-wire wear 80-fold.
· Led team that validated current guide wire lubricant per ISO standards, resolving FDA 483 item and permitting continued sales of $80M per year of product.
Quinton Instruments, Seattle , WA
Quality Engineer
Facilitated dialysis catheter product development projects by providing quality engineering perspective. Audited R&D functions.
· Developed knowledge of federal and international regulations surrounding design control.
· Designed $100K biocompatibility testing program for all the medical use raw materials to comply with 1995 ISO requirements.
Abbott Research, Inc. (Formerly International Biomedics, Inc.), Bothell , WA
R&D Engineer, Manufacturing Engineer, and then Senior R&D Engineer
Completed development of fiber-optic blood gas sensor. Managed two technicians.
· Invented, optimized and patented an algorithm that removed inaccuracies caused by fiber-optic kinking, eliminating 90% of clinical failures.
· Led clinical response project team that resolved problems surfacing during animal and clinical trials.
· Hired, trained and supervised eight technicians in a variety of technical duties, requiring seven day workweeks, to meet tight testing deadlines.
· Built microscopic, three-parameter, intra-arterial probe and transferred technology to manufacturing, maintaining feedback loop for future improvements.
· Resolved critical issue and reduced development time by eight weeks by applying key carpentry knowledge to fiber-optic connectors.
TEACHING
· Effectively teach project management skills using my experience, class participation and good humor.
Stryker Orthopedics one-day Project Management and one-day Process Mapping programs in Mahwah , NJ
· Customized Stryker’s programs with my experience in the Life Sciences industry to make it understandable to the students. Achieved an average feedback grade of 4.5 of 5.
Cadence Project Management program.
· Converted many Pharmaceutical and Medical Device companies to the CadenceTM program, starting with an executive briefing, then training all the project managers, team members, and functional managers, following up with consulting to reinforce the training.
EDUCATION
B.A. Biochemistry, University of Oregon , Eugene , OR
Certification: Project Management Professional, 1999
PROFESSIONAL AFFILIATIONS
Member of Project Management Institute since January 1999
Member of PMI’s Product Development and Pharmaceutical Special Interest Groups since January 1999
Member of Mensa since 2003
PATENTS
Configuration fiber-optic blood gas sensor bundle and method of making US 5,047,627
Method for hydrating and calibrating a sterilizable fiber-optic catheter US 5,328,848
A method and apparatus for detecting and compensating for a kink in an optical fiber US 5,565,976
Medical emulsion lubricant European 01920707.5-2114-US0109405 US 6,054,421
Medical emulsion lubricant and delivery of drugs US
Medical emulsion lubricant and delivery of drugs US
Anatomically curved Aortic Arch graft European 02790033.1-2310-US0238865 US 6,770,090
PUBLICATIONS
“Planning a Computer Systems Validation Project” Contract Pharma: April/May 2002
“Assumptions improve project and product quality” Quality Assurance Journal: June 2003
“A Practical Method to Track % Complete using Earned Value Analysis” PMI Pharma/SIG Newsletter Mar 2005
COMPANIES ASSISTED WHILE CONSULTING
Abbott Labs
Arrow
Astellas
Aventis-Dermik
Barr
Bayer
Biogen-Idec
Boehringer-Ingelheim
Carpenter Technologies Cuno
Cymer
Dermik Labs
IVAX
KV Pharmaceutical
LifeCell
MannKind
Merial
Millennium
Net-App
Novartis
Office Max
Organon
Otsuka
Pharmagistics
Respironics
Roche
Sanofi-Aventis
Sepracor
Schering-Plough
Starbucks
Stryker
Teleflex
Triple-i
Wyeth
PRESENTATIONS
Planning a CAPA Validation Project, Medical Design and Manufacturing Conference West: Feb. 2003
Develop Strategies for Overcoming Lack of Supporting Documentation for Compliance of Legacy Systems,
Validating Legacy Systems. Barnett International: March 2003
Systems Validation to Ensure Compliant Sample Accountability, Center for Business Intelligence: May 2003
Planning a CAPA Validation Project, Medical Design and Manufacturing Conference East: June 2003
Computer Systems Validation. A growing and Profitable industry, NJ PMI Symposium: May 2004
Validating Great Plains Software at a Life Sciences Company, Microsoft Convergence: March 2005
Systems Validation to Ensure Compliant Sample Accountability, Center for Business Intelligence: May 2005
Project Management in Early Stages of Biopharmaceutical Development; Earned Value; A Practical Approach to managing scientific projects, Institute for Validation Technology: June 2005
Techniques for Managing Vendor Projects to Budget, Institute for Validation Technology: February 2006
Effectively Planning and Executing a Comp. Syst.Validation, Regulatory Affairs Professional Society: June 2006
Project Management Techniques (Webcast), Regulatory Affairs Professional Society: April 2007
Project Planning and Reporting (On-Line Course), Regulatory Affairs Professional Society: May 2007
Earned Value, Project Management Institute Pharmaceutical Specific Interest Group: April 2008
A Practical Approach to Managing Scientific Projects, International Pharmaceutical Academy
Linking Budgets and Resources with Project Timelines, International Pharmaceutical Academy
Medical Device Risk Management, Quality and Productivity Solutions: September 2008
Various Project Management Lunch and Learns, Pharmaceutical and Medical Device companies: 2007 - 2010
