Engineer Development

*** *********** **** *. ****** Cesarone 610-***-****

Douglassville, PA 19518

**************@*****.*** cell: 610-***-****

Summary of Qualifications

Driven senior engineer with a proven track record of building, managing and retaining successful product development teams. Possess strong analytical and problem solving skills along with effective verbal and customer facing communication skills. Diverse experience in planning, directing and conducting engineering research and development activities in the development of new products. Experience and strengths include:

•Product development launch and post management

•Outstanding leadership, presentation and customer facing communication skills

•Thorough understanding of design controls

•Surgeon and sales rep education and training

•Thorough understanding of materials and mechanical testing

•Thorough understanding of ASTM/ISO,FDA/CE requirements

•Strong team building whose impact is far greater than the sum of their parts

•Knowledgeable of IP review and filing

applications

Professional Experience

SpineWave, Shelton, CT March 2012 to February 2013

Principal Engineer

Responsible for leading the project and the coordination of the R&D team efforts, support staff and outside vendors while actively participating in scientific and engineering analysis and design for the project.

• Offer design solutions in generating product/pathology market assessment with product development. Make appropriate recommendations for future development activities.

• Develop solutions to design and manufacturing problems of complex nature.

• Work as contributing team member and project leader. Effectively interact with peers, cross functional teams and outside vendors to resolve problems and keep project on track.

• Set the direction of test protocols and assist in testing process with emphasis of data analysis useful in the educational and selling tools in abstract/poster publications.

• Attend surgery/labs as required.

Globus Medical, Audubon, PA.

August 2008 to June 2011

Group Engineering Manager, Biomaterials

Manage product development in the core areas of implantable bone graft materials. Contribute as a team player coordinating a group of product development engineers and product managers in the launch of new products.

• Manage the development of new products using existing and emerging technologies in accordance with design control requirements.

• Coordinate the publishing of marketing information sheets, technique guides and technical articles with the launch of new products.

• Coordinate test programs and animal studies and compile the documentation to support FDA/CE marking of new products.

• Plan and lead the verification and validation activities in compliance with design controls procedures.

Applied Spine Technologies, New Haven, CT June 2005 to August 2008

Director, Research and Development

The Director of R&D has full responsibility for the key functional requirements of the Stabilimax NZTM product. Lead the development of the implants, instruments and packaging to ultimate completion of the preclinical verification and validation requirements. Manage R&D, manufacturing and quality staff to develop manufacturing processes and optimize existing processes.

• Prepared development plans and budgets including ROI capital expenditures for new equipment used for the manufacture and inspection of the implant components.

• Prepared biomechanical test protocols based on human physiology and ASTM standards.

• Train surgeon advisory board and primary investigators in the clinical indications and use of the StabilimaxTM implant system.

• Developed and released internal SOP’s and work instructions in compliance with document control procedures.

• Maintain an atmosphere of cooperation and collaboration with team members while maintaining focus on accelerating the development timeline.

DePuy Spine, Raynham, MA December 2000 to June 2005

Senior Product Development Engineer

Provide the appropriate direction and mentoring to others to lead the development team efforts for new and existing implants and instruments. Obtain specifications from physicians, technical experts, regulatory and manufacturing while adhering to design control procedures.

• Prepare and review IP for patent application and protection.

• Mentored newly hired staff and colleagues on spinal anatomy, biomechanics, current portfolio of products and internal procedures.

• Collaborate with associate groups to write and implement internal SOP’s in compliance with FDA and GMP guidelines to respond to changing business conditions.

• Increased vendor pool to streamline response time and regulatory submissions.

• Sustain current product offering by expanding user base and improved techniques.

AcroMed, Inc., Cleveland, OH November 1997 to December 2000

Customs and Specials Business Partner

Lead the creation of product line extensions, complying with FDA regulations while sustaining legacy product life cycle while improving overall profit margins. Analyze proposed product specifications to determine feasibility of proposals. Develop and execute business plans, forecast and develop market assessments while managing business expenses.

• Demonstrated ability to effectively communicate business plans and product design requirements to management.

• Lead the development of product line extensions to sustain current portfolio of products complying with FDA and GMP regulations.

• Resolve product performance issues while sustaining supply chain continuity and improving business unit profit margins.

• Established relationships with Japan and Americas to provide key surgeons with custom products.

Synthes Spine, Paoli, PA. June 1992 to November 1997

Product Development Engineer

Developed implants and instruments for spinal surgical procedures. Work directly with product managers, surgeons, manufacturing and other team members to develop product requirements and concepts for prototype evaluations and clinical trials. Conduct testing for engineering disposition and FDA submission.

• Successfully launched the Universal Spine System.

• Successfully launched the Small Stature Spine System.

• Successfully launched the CerviFix Spine System.

• Co-wrote ASTM F-4 Spinal device test standards and ISO/DIN specifications.

Synthes Orthopaedics, Paoli, PA. February 1990 to June 1992

Draft test protocols in accordance with ASTM test methods. Document test data and report test results to appropriate pathology staff. Provide product development group support in product design recommendations. Maintain laboratory equipment and calibration.

• Co-wrote ASTM test standards for orthopaedic devices.

• Collaborated with FDA in establishing bone screw test apparatus establishing industry standard method.

• Performed biomechanical and mechanical testing of orthopaedic implants to meet specification.

Special Skills

Solid Works 2012

Geometric Dimensioning and Tolerancing

Patents

US 6,682,534 January 27, 2004: Endplate Preparation Instrument, The operation of this instrument has been cannibalized by many patents. The intent of the instrument allows the user to prepare the superior and inferior endplates for bone graft insertion while maintaining a portion of the integrity of the endplates to prevent subsidence of the graft. In addition, blood flow is permissible.

US Application 10/908008 April 25, 2005: Anterior Bone Plate System and Method of Use. An anterior bone plate system is provided that promotes osseous fusion and allows subsidence while restricting extension. The bone plate system requires a minimum number of screws for securing the plate onto bone, thus reducing the amount of osseous tissue damage incurred.

Publications

“Techniques in the Application of ISO 9585 Test Method for the Determination of Bone Plate Bending Properties”, Presented at the ASTM Symposium on Clinical and Laboratory Performance of Bone Plates, 1994

“An Evaluation of the Influence of UHMWPE Test Block Design in the Mechanical Performance of Bilateral Lumbar Corpectomy Constructs”, Presented at the ASTM Symposium on Spinal Implants: Are we evaluating them appropriately?

Education

Eastern College

St. Davids, PA.

Masters of Business Administration

June 1997

Spring Garden College

Chestnut Hill, PA.

Bachelor of Science Degree in Mechanical Engineering Technology

December 1989

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