Consultant
PRINCIPAL INDUSTRIES SERVED
- Biomedical
- Medical
- Pharmaceutical
EDUCATION
This expert has a B.S. in Electrical Engineering and a B.S. in Biomedical Engineering, received from the University of Bridgeport.
Other education this expert has had includes:
AAMI Certified Clinical Engineer, Association for the Advancement of Medical Instrumentation Training, ISO 9000 Auditing, Crosby Quality Education System (QES), Statistical Process Control (SPC), MS Office, Project Management, Orcad Electronic Schematic Capture CAD, Solidworks Solid Modeling CAD
EXPERTISE AND SERVICES
Biomedical Design Consultant, Medical Device Expert ConsultantThis consultant specializes in senior design engineering and project management, with over 20 years experience in full lifecycle medical device product development, from concept to commercialization. This expert has a diverse background in all areas of biomedical, electrical, mechanical, and packaging engineering.
Additional areas of expertise this consultant has include engineering team leadership, ISO 9000 design control, CE Mark requirements, and domestic and European product safety testing standards. This expert also has experience in the fields of handheld disposables, reusable, microprocessor control instrumentation, and solid modeling.
This consultant also specializes in schematic capture techniques, design control, product specification, and quality plan preparation. Other areas of this consultant's work experience include product testing, materials, safety, and effectiveness. Lifecycle, documentation, process development, process validation, and regulatory compliance are other areas of this consultant's expertise.
This expert has conducted numerous studies and has extensive experience in areas including implantable inserters, endoscopic instruments, destructive and life testing, and instrument repair. Other areas of study and experience for this expert include electrosurgical safety boots, endoscopic dissectors, and ultrasonic surgical aspirator product improvement, and reusable, disposable endoscopic tissue grasping-dissection forceps. Also, this consultant has experience in the fields of suction irrigators, microkeratomes systems, endoscopic instrument insulating connector, ultrasonic and electrosurgical energy combination.
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy Associates Inc.
Providing project management, design engineering, electrical engineering, biomedical engineering, medical device product development, failure analysis, forensic engineering, consulting and related expertise for a wide variety of clients.
Director of Development, medical device company
Provided development support for products used on cardiac tissue in both concomitant and closed-chest beating heart. Initially directed the QA function to re-establish that department and was transferred to Director of Development. Managed R&D department administration functions and planned work for seven engineers, techs and designer. Organized QA department to ensure company to meet QS hiring QA System Engineer, QA Tech and Doc Control Administrator. Wrote procedures to comply with design control and orchestrated all other quality procedure development. Managed QA personnel until new RA/QA Director was hired and transferred, at which 95% of the procedures were completed and department was fully functional. Was promoted to Director of Development, four direct reports and three indirect reports. Managed department budget $2+ million. Managed day to day activities, nurtured engineers in design control by writing procedures and providing training to them. Managed projects for several design enhancements to Laser, Controller and associated disposables. Developed new products for both lines. Developed technologies to enable closure of box lesion set as well as addition lesion sets. As part of the management team, was involved in the overall company strategy for bringing products to market, conserving cash runway and burn rates.
Project Manager, Design Engineer, Consultant
Provided clients with engineering management services, designed and developed medical device products including handheld disposables, resuables, and microprocessor control instrumentation utilizing solid modeling and schematic capture techniques. Managed all aspects of development projects, design control, product specification and quality plan preparation, product testing (materials, safety/effectiveness, lifecycle), and documentation. Developed and validated processes. Ensured compliance with regulations as well as 510(k) filing guidelines. Solved mechanical design problem with an implantable inserter for Restore Medical and managed new design of the device to reduce costs and increase profits. Established design control systems to enable numerous companies to obtain ISO 9000 certification.
Senior Project Engineer, Advanced Engineering, Endosurgery, Davis & Geck Inc.
Project manager for fast-track commercialization of new endoscopic instruments; ensured adherence to strict schedules, with time-to-market for a main platform set at ten months and line extensions at two months. Led technicians and engineers; prepared schedules for product development and testing, including destructive and life testing. Assessed OEM vendor capabilities to ensure alignment with the company's marketing plan. Established and directed technicians within an instrument repair department. Designed and patented an electrosurgical safety boot for use on endoscopic dissectors.
Senior Project Engineer, Research and Development, Valleylab, Inc.
Project manager responsible for launching new and improved ultrasonic surgical aspirator products to market utilizing a project team concept. Led the improvement of existing designs to increase reliability and profitability. Coordinated the release of over eight products that generated sales of over $35 million. Designed and implemented the disposable steam/ETO sterilizable product line and co-designed a steam/ETO sterilizable straight and angled handpiece as well as a switching mechanism.
ADDITIONAL EXPERIENCE
Orchestrated the release of over 200 products in two years for Davis & Geck Inc., including unique, high-quality 5mm/10mm reusable and disposable endoscopic tissue grasping/dissection forceps and suction irrigators that accounted for sales of over $25 million.
Repackaged Valleylab Inc.'s disposable product line to drive profits through manufacturing cost reductions and improved customer appeal.
Project managed Interceptor Modular Scissor program for Smith & Nephew.
Project managed and designed two microkeratomes systems for Becton Dickinson.
Participated in an R&D project for EnteroMedics, designed and built nerve stimulator and electrodes for vagus nerve stimulation.
Project managed a root cause analysis for Restore Medical on implant deployment device.
Conducted gap analysis in design history files for Gaymar Industries on all products and update products DHF.
Performed engineering and quality functions for CircuLite, USA and German facilities.
Managed major design enhancements for MedicalCV Laser Ablation disposables, Controller and Laser.
Re-established QA Department.
PUBLICATIONS
This expert is the co-holder of patents for an endoscopic instrument insulating connector as well as a method of combining ultrasonic and electrosurgical energies.