Engineer Medical Device
Resume:
Jeffrey E. Bishop
Home: 813-***-****
Email: *******.*********@*****.***
Summary: Consistently contributed to the company’s bottom line through developing and implementing process improvements that significantly reduced manufacturing costs. Developed and launched new products that created organic growth for the company and allowed for the expansion into new markets. Utilized my 20+ years of experience and training in medical devices, industrial manufacturing, and food processing to drive continuous improvement and lean manufacturing efforts, improve quality, and perform root cause investigations as part of corrective and preventative actions. Led teams on several projects utilizing principles from the Kaizen and Six Sigma methodologies. EXPERIENCE:
Bovie Medical Corporation 2009-2017
Medical Device / Equipment Manufacturer, Clearwater, Florida Project Manager
Led new product development efforts for medical device side of the business as well as process improvement efforts. Conducted CAPA projects from investigation to completion / implementation. Specification, purchase, and installation of capital equipment (e.g. Sodick Wire EDM and Branson Ultrasonic Welder). Provided daily direction for mechanical designers as well as mentoring them in their careers. Conducted patent reviews and served as the engineering resource for intellectual property discussions with corporate counsel.
• Consolidated the Bovie Canada facility into the Bovie Clearwater facility which included preparation of inventories, Customs documentation, rigging, and transportation of equipment from Windsor, Canada to Clearwater, Florida.
• Lead project team for the development of the vessel sealing technology acquired by Bovie. Also acted as the Engineering resource on the project which included developing a burst pressure testing fixture and its associated procedure.
• Developed and released several accessories that are to be used with a new electrosurgical generator
(IDS310). Improved the interface between the accessories and the socket of the generator to reduce the amount of force that is required to insert and withdraw the devices which increased customer satisfaction. This improvement was also carried over to legacy products with a similar interface.
• Authored, implemented and trained operators on installation, operation, setup, and maintenance procedures for various pieces of production equipment and inspection equipment / processes.
• Had management responsibility for Mechanical Designers and Machine Shop / Toolroom personnel
• Leading project team to introduce an arthroscopic ablator that does not require dedicated capital equipment and operates at 1/3 of the power when compared to market leaders. This is the first Bovie branded arthroscopic RF instrument.
Ascent Healthcare Solutions 2009
Medical Device Reprocessor, Lakeland, Florida
R&D Special Projects Engineer
Utilized my knowledge of medical device design and use to develop processes to clean, disinfect and reprocess various medical devices. These devices covered numerous intended uses from patient monitoring, arthroscopy, resection, vessel, sealing, and cannulae. Advised quality department on proper use and testing of devices based on my experience with design testing and operating room observations.
• Examined the process of reprocessing arthroscopic shavers from Linvatec, Smith & Nephew, and Stryker to find the root cause of stress cracks that were appearing in the hubs prior to repackaging. Recommended changes to process and associated chemistry to process owner.
• Developed a cleaning process and conducted validation activities for a line of Arthroscopic Ablation wands
• Assisted other R&D engineers with developing a test method and evaluating the ability to reprocess the Gyrus PK vessel sealing device
• Initiated and led an effort to understand a new probe recognition and use-limitation technology that was implemented on an ArthroCare Arthroscopic Wand.
ConMed Linvatec, Largo, Fl 1999-2009
Medical Device Manufacturer
Research and Development Engineer (2002 – 2009)
Created and released a new line of orthopedic saw blades (42 SKUs) as well as line extensions of existing products. Compiled, released and maintained Design History Files (DHFs), which contained the Design Inputs, DFMEA, PHA, Regulatory Analysis documents (510k submissions), Verification and Validation testing, and the CE marking documents required by the Medical Device Directive (MDD). Acted as technical / design consultant for the redesign of tooth setting and grinding fixturing as well as other associated manufacturing tooling. Provided technical support to Quality Engineering to close complaints, determine root cause of quality issues, as well as the implementation of corrective and preventative actions.
• Increase in revenue of $140K after the first six months (post-release) for a new arthroscopic shaver blade which was part of a platform consisting of 5 new blades.
• Provide technical leadership and project management for both new product development and sustaining engineering efforts related to the design of disposable arthroscopic and orthopedic surgical devices
• Achieved an 85% reduction in clogging issues associated with arthroscopic shaver blades (this project resulted in the development of a standard lab test and protocol that is now used to screen every new design for clogging performance prior to release).
• Saved over $300k worth of inventory by developing a method to resolve a design issue where the inventory was scheduled to be scrapped. This effort resulted in improved performance of an auger style device which was being released as a new product.
• Delivered a working prototype spinal blade for a joint venture in less than 2 weeks from concept to finished device.
Manufacturing Engineer II: (2000-2002)
Provided manufacturing engineering support to the blade / bur grinding operations and other disposable device factories.
• Savings of $200K were delivered the first year followed by a second year’s contribution of $300K by developing and implementing process improvements and cost reductions. Manufacturing Engineer 1: (1999)
Performed process verifications and validations. Participated in several Lean Manufacturing initiatives (3P Events, Value Stream Mapping, Cause and Effect Matrices, Kaizen, and 5S Events) which covered many different production areas such as Specialty Assembly, Hoses, Accessories, Shutt Instruments, and Grinding.
• Saved $20K worth of material by reworking inventory and implementing a corrective action. Participated in process development with the bur blank supplier to solve bur head attachment issues, cellularized manufacturing, implemented a machine work-holding modification, which resulted in increased productivity of $150K.
• Selected by Sr. Management to provide technical development for Manufacturing Specialists as well as mentoring aspiring machinists through the Linvatec Apprenticeship Program MonierLifetile L.L.C. Lake Wales, Fl 1998 – 1999
Manufacturer of Concrete Roofing Tiles
Process Engineer / Quality Assurance Manager:
Managed a nine-person Quality Assurance department and budgeted for the departmental operating expenses as well as for customer concessions. Worked with the maintenance department to effect changes in the manufacturing processes. Personally responsible for all product produced and placed into inventory with direct reporting relationship to Vice President of Operations.
• Reduced complaint payments from $59K the first month to $19K, $9K, and $16K the second, third, fourth months respectively.
• Initiated the implementation of a plant wide S.P.C. program.
• Saved approximately 30% in cost of pigments by switching plant over from purchased pigment to mixing our own pigment on site, automation of curing kilns, installation of new automatic racker and installation of old automatic racking system on a previously manual production line.
• Worked with sealer vendor to develop a new sealer with improved stability. Previous Work History Includes:
Black & Decker (U.S.) Inc. (SAWELL), Tampa, Fl 1995 - 1998 Manufacturer of accessories (i.e. Jig saw blades, Band saw blades, Reciprocating Saw Blades) Mechanical
/ Manufacturing Engineer:
Lykes Brothers, Inc. Meat Division. Plant City, Fl. 1993 Manufacturer of food products (i.e. Lunch meats, bacon, and hams) Engineering Intern:
EDUCATION
Completed course work toward Masters of Science Degree: University of South Florida. College of Engineering. Tampa, Fl. University of South Florida. College of Engineering. Tampa, Fl. Major: Mechanical Engineering
Bachelor of Science Degree (BSME)
HONORS AND AWARDS:
Passed Florida State Board of Professional Engineers E.I.T Examination Tau Beta Pi: Member since 1994
Golden Key: Member since 1994
Thompson M. Lykes Memorial Scholarship
Eagle Scout with Bronze Palm
Professional Development:
Bovie Medical: Project Management Seminar (Fred Pryor), Communicating with Tact and Professionalism (Fred Pryor), 2015 Engineering Leadership Seminar (SME Chapter 159), The Science of Sterilization Seminar (Nelson Laboratories)
ConMed Linvatec: Six Sigma methodology as well as Design for Manufacturing, Design for Assembly, and in the use of Solid Edge v.10 – 15, Fundamentals of Geometric Dimensioning & Tolerancing (GD&T) based on ASME Y14.5M-1994, Kepner Tregoe seminar for Conducting and Documenting investigations, D.O.E. training, ECO training as well as Process Verification & Validation training. Black & Decker: Institute of Advanced Manufacturing Sciences, Grinding Principles and Practice
Contact this candidate