1. MICHAEL WILCZEK
2099 Powers Ferry Rd. Apt N ∙ Marietta, GA 30067
(714)458-9686∙ Michael.Wilczek@duke.edu
PROFILE
Medical device industry professional with expertise in new product development. Would like to continue to develop skills to identify,
define, and develop medical device products. Experience performing regulatory, quality, and research activities. Would like to gain
clinical experience in a hospital setting. Passionate about the healthcare industry and making a difference in peoples’ lives.
EDUCATION
DUKE UNIVERSITY THE FUQUA SCHOOL OF BUSINESS, Durham, NC
Master of Business Administration, (Cross Continent Program), December 2011
Concentration: Health Sector Management; Courses: Financial and Managerial Accounting, Managerial Effectiveness, Decision
Models, Micro and Macro Economics, Statistical Models, Corporate Strategy, Marketing, and Operations Management
PURDUE UNIVERSITY, West Lafayette, IN
Master of Science in Biomedical Engineering, December 2007
Thesis: Mimicking Lumbar Musculature for In Vitro Testing Applications to Further Progress Current Testing Methods
Relevant Courses: Tissue Engineering, Biomaterials, Occupational Ergonomics, and Kinematics & Dynamics of Human Motions
VIRGINIA TECH, Blacksburg, VA
Bachelor of Science in Mechanical Engineering, May 2004
Senior Design Project: Hydrogen powered hybrid electric vehicle; controls and heat transfer development
EXPERIENCE
2008 –2011 ZIMMER INC, Warsaw, IN
Senior I Development Engineer
Developed a variety of new products including an antibiotic hip cement spacer, an acetabular cup, and a new
antimicrobial surface coating
Performed a wide range of product development activities such as: Leading a 20 person cadaver lab with four
surgeons (design validation), Functional Relationships Analysis (FRA) to complete design verification,
Geometric Dimensions and Tolerance (GD&T), and modeling with Unigraphics (UG)
Provided post market product surveillance support by processing complaints, CAPAs, investigating product
nonconformance (NCRs), quality investigation reports (QIRs), and health hazard evaluation screenings (go/no
go on recalls)
Led various hip implant development teams (3~5 people) responsible for design change requests, process
change requests, design and process risk analysis (FMEAs), and product manufacturing transfers
Supplied information essential to gaining regulatory approval for EU Upclassification (Bsi), CE markings,
PMA supplements (FDA), 510k submissions, and onsite audits
2004 – 2005 INTERFACE ASSOCIATES, Laguna Niguel, CA
Development Engineer
Led a $10 mil project to design a process to create nylon membranes out of polymers for catheters in medical
devices. Utilized injection molding to form polymer membranes that were wrapped on catheters and used for
stent deployment
Provided development support to assist the clean room in achieving ISO 9000 certification
Summer
2002 – 2004 DUPONT, Wilmington, DE
Engineering Mechanics – Internship
Calculated deformations, stress concentration forces, and peak stresses for flanges and pressure vessels using
finite element analysis (FEA) in the structural stress field and proposed solutions for process plants about design
failures. Gathered information from the customers to find solutions that avoid mechanical failures
ADDITIONAL INFORMATION
Selected as a research assistant and teaching assistant while at Purdue University
Memberships: Volunteer at Grady Hospital, Volunteered with Big Brothers Big Sisters, Biomedical
Engineering Student Association member, and Duke University HSM concentration class representative
Computer Skills: Finite Element Analysis (FEA), Unigraphics (UG), LabView, and Matlab