JANET B.

CALLAHAN
30 Market Street, Lowell, MA 01852 ▪ Cell phone: (704-798-1391) ▪ JBC6671@AOL.com

SUMMARY OF QUALIFICATIONS
Medical device industry scientist and project manager is adept at administration of all phases of
medical device product design, development, implementation and support. Skilled with project
planning and team coordination. Working knowledge of the current regulatory climate.

CORE COMPETENCIES
Product Inception, Project Planning and Execution Team Coordination
Medical Device Quality and Regulatory Requirements Strategic Plan Implementation
Medical and Technical Laboratory Management Medical Diagnostic Expertise
Analytical and Statistical Competence Coagulation, Hematology Specialist

PROFESSIONAL EXPERIENCE
Instrumentation Laboratory, Bedford, MA 2007-present
Principal Scientist/Project Manager
• Design, initiate and manage development of analytical methods for new and highly automated
analyzers.
• Lead a team of scientists.
Duke Univirsity Medical Center, Durham, NC 2004-2007
Analytical Specialist
• Responsible for Quality Assurance, Quality Improvement, Regulatory compliance and
operations in a busy, 24/7 academic hospital laboratory.
• Key duties included patient data review, method and process development, and liaison with
the medical staff.

American Red Cross Laboratories Headquarters, Charlotte, NC 2000-2004

Project Management Officer
• Responsible for the planning, deployment and implementation of multiple viral, nucleic acid
and immunological methods and processes in the multiple National Testing Laboratories
located across the US.
• Manage Headquarters Development Teams of Regulatory, SOP Development, Validation and
Technical Support and promote relationships with OEM R & D departments.

Organon Teknika Corp. (OTC) Durham, NC 1986-1997

Thrombosis and Hemostasis International Area Manager, Systems Integration Manager
• Implemented strategic plan for Marketing and Research & Development in a medical
device company.
• Facilitated worldwide basic and product related research projects which supported worldwide
(35 countries) marketing effort.

Instrumentation Laboratory, Lexington, MA 1985-1986

Regional Technical Director.
• Field troubleshooting for chemistry reagents and instruments.
North Carolina Memorial Hospital, Chapel Hill, NC. 1972-1985
Medical Technologist, Supervisor and Medical Technology Instructor
• Founded a Special Coagulation laboratory in an internationally respected coagulation center.
• Developed specialized applications for medical devices before automated methods were
commercially available. Trained Medical Technologists, Medical Residents and Fellows.

TECHNICAL SKILLS

Design Control ISO; Design Control IVD; Medical Devices Guidance Docs: CLIA; CLSI: CAPA: Design
History Files; Microsoft Project, Word, Visio, PowerPoint: Lotus Notes; various Statistical Programs

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