Engineer Design

Location:

2360

Posted:

July 13, 2010

Contact this candidate

Resume:

William Kennefick

** ***** ****** ( Plymouth, MA 02360

**************@*****.*** ( cell 508-***-**** h. 508-***-****

Qualifications Profile

Goal oriented medical device engineering professional with over 20 years in

the medical device industry. An easy to work with team player working

proficiently with all business groups committed to successful results in

all aspects of product development from concept to product launch. Well

rounded product development experience developing implants and

instrumentation for Orthopedic Hips, Knees, Podiatry, Neurosurgical, Spine,

and Dental. Experienced in OR protocol, surgeon interface, cadaver labs,

and product training. Solid design and development expertise with GD&T, 3D

modeling, ProE V18, Unigraphics NX2, and Solid Works V10, proficient in

sketcher based parametric modeling. A proven track record of expertise with

problem solving innovation, design materials, and manufacturing operations.

Adept in machine shop practices and manufacturing processes working well

with both in-house and external manufacturing. Working knowledge in both

machined metal parts and injection molded plastic part design. A strong

work ethic combined with a commitment to excellence in all projects

undertaken.

Professional Experience

Sr. Design/Product Development Engineer

6/2009 - Present, ConforMIS Inc. Burlington, MA.

Key Responsibilities

. Responsible for existing released implant and instrument enhancements

as well as supporting new projects while adhering to aggressive

timelines.

. Communicate with design surgeons, Marketing and independent entities

to gain knowledge into product design requirements.

. Develop project plans to execute assigned projects

. Using Solidworks V10, create product designs according to agreed upon

design criteria.

. Write required documentation to comply with QSR and CE guidelines

. Develop test protocol with research labs to complete required testing.

. Overseeing of prototype fabrication at suppliers.

. Develop design documentation for the manufacture of product including

drawings, product specifications and product validations.

Sr. Design/Product Development Engineer

March/2007 - April/2009 Keystone Dental Inc., Burlington, MA,

Key Responsibilities:

. Sr. Design/Product Development Engineer responsible for the successful

design and launch of the XP1 Dental Implant System.

. Well versed in "wearing many hats" at the start up stage of a company.

Responsibilities included concept, design, machining, manufacturing,

inspection, and quality compliance.

. Work with consulting surgeons developing surgical protocol, implant and

instrument design

. Skilled with procurement of materials and manufacturing methods, working

closely with internal and external manufacturing to resolve issues

between design and manufacturing.

. Responsible for executing design changes and approving all other design

engineer's output.

Sr. Design Engineer/Team Leader

Jan 2000 - Mar 2007 DePuy Spine, Raynham, MA,

Key Responsibilities:

. Providing design criteria and solutions for all pathologies within

Spine both implant and instrumentation.

. Actively work in a team environment with marketing, project leaders,

and designing surgeons to establish and document design criteria for

implantable medical components, develop innovative solutions to

satisfy or re-establish those criteria.

. Responsible for managing projects and priorities to a five man in-

house prototype manufacturing department as well as outside

manufacturing sources to ensure that design intent gets properly

translated into finished good devices and that designs are

manufacturable and cost effective for all project teams.

. Proficient with Unigraphics NX2 for fixture and component models.

Expert in drawing preparation submitted for production release.

. Provide accurate and precise time, cost, and resource assessments

plans to project management

. Three years in Team Leader role with 8-14 direct reports. Responsible

for work load delegation and individual employee development.

Sr. Design Engineer

Jan-1999 - Jan-2000 Codman, Raynham, MA.

. Responsible as the lead Design Engineer for all design related aspects

of a cranial absorbable fixation system "Craniosorb" from concept to

production.

. Responsible for interfacing with in-house and external manufacturing

vendors to ensure that design intent gets properly translated into

finished good devices and that designs are manufacturable.

. Use of Unigraphics V18 for all fixture and part models and drawings

being submitted on ECR or for development.

Design Engineer

Jan-1996 - Jan-1999 Johnson & Johnson Professional, Customs and Special

Products Raynham, MA.

This group was responsible for 9-million dollars worth of competitor

surgeon conversions to Johnson & Johnson Orthopaedic users in 1999.

. Working independently as the Lead Design Engineer for custom hip

implant and instrumentation, provided direct interface with surgeons

and sales force in order to design major components or major portions

of a functional system to develop or improve products and facilitate

manufacturing operations.

. Manage all production orders being manufactured at our New Bedford

machine shop.

. Develop models and drawings utilizing ProE v18 and develop preliminary

and released layouts, sketches, and notes necessary to complete a

design project.

. Provide imaginative, thorough and practicable solutions to a wide

range of medical device design challenges.

Design Engineer

June1990 - Jan1996 Johnson & Johnson Orthopaedics, Raynham, MA

. P.F.C. Hip, R&D Product Development, provide implant and

instrumentation designs, revise and redesign existing

instrumentation, prototypes, development of new instrumentation

concepts, layouts and technical drawings.

. Initiate change requests as well as complete major complex change

requests. Utilization of Unigraphics

. Coordinate, evaluate, and disposition design or manufacturing