BioMedical, HealthCare, Mechanical Engineering, Medical Device Expert Consultant Resume
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Resume of DIV
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  • BioMedical Industry
  • HealthCare Industry
  • Medical Device Product Development
  • Patent Infringement
  • Mechanical Engineering

San Diego State University, San Diego, CA : Bachelor of Science – Mechanical Engineering

 San Diego State University, San Diego, CA : MBA Coursework

 A seasoned Engineering professional with over 32 years of Product Development experience in the HealthCare and BioMedical industries. Extensive systems level experience in Drug Delivery, Respiratory Care, Vital Signs Monitoring, and Blood Handling product & technology development, Program/Project Management, Risk Management & Analysis. Utilizes excellent collaborative skills to achieve the most from people and technology. This expert brings a great appreciation of effective FDA Quality Systems, ISO 9001 / ISO13485 Quality Management Systems regulation application to all projects. Also has over 18 years of Expert Witness experience in the areas of Medical Device Product Liability and Patent Infringement. 

Consultant, Kevin Kennedy Associates, Inc., Indianapolis, IN

 Providing expertise in medical device product development and mechanical engineering in the health care field to a wide variety of clients.

 A major Product Development Company – San Diego, CA

 International product development company based in Australia specializing in Consumer and Industrial products, Life Science, Diagnostics, and Medical Devices.

 Senior Consultant / Program Manager – North American Operations

 Provides part-time consulting in the capacity of Senior Mechanical Engineer and Program Manager for various medical device product development projects. Additionally, advises in the development of new Clients and business in the Medical Device markets in North America.

 A major Consulting Company

 Technical Consultant specializing in Medical Device Product Development 

 Principal Consultant

Provides design and development consulting services both as an independent consultant and in conjunction with various consulting associates:

 Products & Areas of Expertise:

 IV Drug Delivery Systems

IV Disposable Sets & Components

Insulin Delivery Systems

Drug Injector Pens

Dialysis Systems & Disposables

In Vitro Diagnostic Systems

Liquid Drug Inhalers

Pyrolitic Carbon Implants

Thermal Droplet Generation

Blood Pressure Monitoring Systems                                                                                                                         

Expert Witness – Medical Devices

Pulmonary Breathing Circuits

Digital Thermometry

Prostrate Seeding Needles

Liquid Biocompatible Adhesive Delivery

Custom Orthotics

Medical Support Appliances

Liquid Drug Humidifiers

Test Fixture Design

Manufacturing Process Development

Some Specific Experiences:

  •  Program Director for new Blood Separation & Collection System product line
  • Co-invented a peristaltic blood pumping and control system for portable dialysis.
  • Designed and optimized an insert molded ultrasonic drug aerosol generation device
  • Developed several conceptual clinical and disposable Inhaler devices
  • Designed low cost disposable filtering device for a Chlamydia STD diagnostic test kit
  • Developed Award winning fluidics design for cassette based clinical diagnostic system for DNA sample processing – Clinical Micro Systems & Nanogen Inc.
  • Investigated patented very low flow precision technology for application to drug delivery and blood handling devices.
  • Conceived and developed a unique drug evaporation system integrated with state-of-the-art Hudson humidifiers and Siemens ventilators
  • Directed Engineering design efforts for an Insulin Pump start-up company – Bionica, Inc.
  • Optimized a patented venting method for sterilized laryngeal mask products.
  • Developed a unique drug compatible PellathaneÔcoated heater wire for breathing circuits
  • Qualified a unique pressure sensing sub-system by optimizing disposable / sensor interface
  • Developed RF welding process for custom pneumatic orthotics

 Alaris Medical Systems, San Diego, CA (Now part of Carefusion, Inc.)

 Largest U.S. medical fluid delivery system and vital signs monitor manufacturer.

 Technical Leader – Development Engineering

Worked in a cross-functional team environment with Marketing, Quality, and Manufacturing Team Leaders and facilitated the product concept generation, design feasibility, and business plan generation for the Signature Edition program. This was Alaris’s first “Heavy-weight” program team and was run as a company within a company.

Provided engineering management and supervision to all electrical, mechanical, software, and disposables engineering personnel (~30 FTE) for the inception, development, and introduction into production of IVAC’s largest product development program in its’ history (Signature Edition).

Directed the technology investigation, selection and development of the Signature Edition fluid delivery platform system, a $35M development effort with over $300M market potential over the following eight years. Participated in upper-management presentations and meetings developing the Signature Edition product positioning, feature selection, and final business plan.

Traveled to 20+ major cities & 50+ Hospitals in the US and Europe to interface directly to Doctors, Clinicians, Nurses, as well as Regulatory Agencies to gather critical drug delivery knowledge to be used in a Quality Function Deployment effort. This effort resulted in the strategic focus of the entire product development program.  

Initiated & directed a competitive technical benchmarking effort of US & European drug delivery systems which provided the foundation for the marketing strategy as well as the fundamental measuring parameters for the design team.

Responsible for both the instrumentation and plastic disposable interface, invention, detail design, and development as well as drug / system compatibility and functional conformance. Established Team Leaders in a consensus driven process to achieve business plan goals with respect to budget, timelines, and company goals. Additionally, all the design specifications, performance qualification plans and procedures, and process plans and procedures were achieved through the same process.

Established the schedule, which all team members utilized for their planning.  Helped define a new development and planning process, which was later used as a model for IVAC’s SOP’s.  These SOP’s were the basis for successful ISO 9000/9001 design control approval. Directly involved in the ISO implementation and qualification process.

Provided technical direction in the review and selection of all out-sourced suppliers and industrial design companies.  Helped train the technical team with new skills in the area of Quality Function Deployment (QFD), DFMA, Design of Experiments (DOE), and the Performance Excellence (PE) process. Utilized all new processes in the development of the Signature Edition program.

Managed all engineering efforts provided by several outside consultants for the program such as IDEO Industrial design / mechanical development and engineering, Battelle Labs for elastomer development, noise and vibration analysis, and Failure Analysis Associates for plastic failure analysis.

Coordinated a patent review process for the program with Fulwider, Patton, Lee & Utecht, a Los Angeles law firm.  Supervised the creation of over 50 disclosures, many of which have been filed with the U.S. Patent Office and granted patent status.

 Department Manager – Development Engineering

Managed all mechanical engineering resources of up to eighteen Engineers with an annual budget of over $1.5M.  Responsibilities included the mechanical development and Market introduction of six new Drug Delivery systems and over a dozen new plastic disposable products.

Provided Technical Consulting participation on corporate teams in the analysis of technology being considered for purchase by the company such as syringe pumps, fluid flow control devices, rotary peristaltic pumps, and specialized medical grade pressure transducers. In this capacity, also provided Expert opinions for Patent and Product Liability issues facing the company. 

Trained in Eli Lilly management program and provided Technical Resources to Lilly instrument and disposable combination products.

Managed the company machine shop with six Model Makers and Machining Specialists utilizing eight production mills and two N.C. mills.

Managed the Development Test Lab, which had four Senior Test Technicians and full laboratory equipment used for design verification testing. Managed the main test strategies and procedures for this test lab.

Directed the effort to select & implement new CAD systems for the mechanical engineering resources, (SDRC-Ideas).  Hired resources to train and maintain the system, and integrated outside suppliers who interfaced their CAM systems.  Directed efforts to establish an in-house CAD-CAM link between the design group and the PCB layout group and machine shop for rapid prototyping. Implemented extensive use of rapid prototyping on all projects such as computer modeling, solid modeling, steriolithography, and urethane cast molds.

 Department Manager – Instrument Sustaining Engineering

Managed mechanical engineering resources of eight Mechanical Engineers with an annual budget of $500K.  Responsibilities included all the mechanical engineering tasks in transitioning several new Instrument products and Disposables products from development to production, while maintaining all existing production needs.

Position supervised the combined departments of Instrument Mechanical and Disposable Products sustaining engineering. Responsible for recruiting, training, mentoring, and reviews of all mechanical engineering personnel.

Responsible for skillful interdepartmental collaboration between Engineering, Quality, Operations, and Marketing to resolve critical design issues impacting production, or field issues demanding immediate attention.

 Carbomedics Inc., Austin, TX

Manufacturer of proprietary Pyrolitic carbon coated bio-implantables (e.g. heart valves)

 Program Manager – Process Development Engineering

 Planned and implemented a $1M project to move an existing Pyrolite® coating facility from San Diego, Ca. to Austin, Texas. Responsible for the technical process / facility improvements, laboratory construction, and coating process validation in the new building.

 Lead the development of a new mono-leaflet implantable heart valve

 Invented anddirected the proprietary design of an accurate rotary dry chemical delivery system to feed zirconium oxide granules to a fluidized bed coating process.

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