DENNIS J. NILAN
25+ years’ experience in the medical device industry and broad experience in clinical trial management, operations, and regulatory affairs. This also includes managing and overseeing all projects, drug development and manufacturing, device development and manufacturing, regulatory and quality functions. Strong experience in start-up companies specializing in medical laser devices with a strong focus in laser eye care. I have worked domestically and internationally in this field.
COGNOPTIX INC., Concord, MA 2007 - 2019
Director – Operations (2015 – 2019)
Manage the Document Control process in conjunction with QA/RA.
Manage all consultants on the Sapphire II Project.
Delivered on-site maintenance service on laser systems involving: installations troubleshooting, repair, and training.
Responsible for contract manufacturing management, device development and quality functions.
Resolve FDA issues related to projects.
Operations & Quality Manager (2012 – 2015)
Created Quality Management system to comply with ISO 13485.
Clinical Trial Manager for feasibility trial. Established and maintained relationships with investigators, site personnel,
and supervised daily clinical trial operations.
Customer Support Manager (2007 – 2012)
Involved in the development and design of medical devices from concept to prototype.
Coordinated various development activities with engineering, external tooling and manufacturing vendors.
OPTOS NORTH AMERICA, INC., Marlborough, MA 1999 – 2007
Distribution Service Center Manager (2005 – 2007)
Managed operations of Distribution Service Center, its’ supply of material. CRM and regulatory requirements and GMP.
Managed spare parts and field inventory of $10 million.
Field Service Manager (1999 – 2004)
Established the customer service operations and field support team.
Customer base grew rapidly over five-year period from 1 to 1400.
GENERAL SCANNING INC., Wilmington, MA 1996 - 1999
Field Service Manager, Eastern Operations (1996 – 1999)
Implemented strategies, policies and programs for key customer accounts. Functioned as the service interface with internal departments including sales, marketing, hardware and software engineering and operations.
SUMMIT TECHNOLOGY, INC., Waltham, MA 1989 - 1996
Field Operations Manager – North America and South America (1993 – 1996)
Established, managed, and assured profitability of Summit customer service operations within the North American and South American regions. This included the hiring, direct supervision, development and technical training of 30 field service engineers.
Field Service Engineer (1989 – 1993)
Delivered on-site maintenance service on laser systems involving: installations troubleshooting, repair, and calibration, training of physician and field, and preventative maintenance. Traveled extensively worldwide to maintain installation base.
Nichols College, Dudley, MA
Continuing education for a bachelor’s degree in Business Management
Wentworth Institute of Technology, Boston, MA
Associate degree in Applied Science in Electronic Technology
Detection of Amyloid β Signature in the Lens and Its Correlation in the Brain to Aid in the Diagnosis of Alzheimer's Disease
System and method for detecting amyloid proteins Issued Dec 29, 2015 and number us US9220403B2
Ocular Imaging Issued Feb 17, 2015 and number us8955969