1. MICHAEL WILCZEK
3310 Englewood Road
Wilmington, DE 19810
http://www.linkedin.com/pub/michael-wilczek/2a/bb2/911
714.458.9686 michael.wilczek@duke.edu
SUMMARY
Experienced Development Engineer highly adept at driving production development efforts to
completion for existing products and new products. Background in Mechanical and Biomedical
Engineering. Extensive experience in the orthopaedic medical device industry. Skilled in variety of
engineering environments and capacities from design of surgical instruments, hip implants, to fatigue
analysis and testing. Flexible.
Experience in
• Design Engineering • Project Management • Product Development
• Quality Assurance • Regulatory Compliance • ISO 9000
• Vendor Management • Customer Service • Post Market Surveillance
• Process Evaluation • Brand Management • Competitive Analysis
TECHNICAL SKILLS
• 3D Modeling / Unigraphics • Prototype Engineering • Acceptance Testing
• Mechanical Design • Medical Device Design • FEA and Fatigue Testing
• Failure Analysis • Technical Troubleshooting • FDA Design Controls
PROFESSIONAL EXPERIENCE
ZIMMER INC, Warsaw, IN 2008 – 2011
Senior Development Engineer
Designed and developed hip implants and instruments within the orthopaedic medical device field.
Explained design analysis decisions and relayed layout drawing information changes to Device
Design team. Performed activities critical to product release and regulatory approval. Led a 3
person team in the concept and prototype generation of an antibiotic hip cement spacer.
• Developed a variety of new products including an antibiotic hip cement spacer, an acetabular
cup, and a new antimicrobial surface coating.
• Complied with FDA Design controls by performing a wide range of product development
activities such as: Leading a 20 person cadaver lab with 4 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.
2. MICHAEL WILCZEK PAGE TWO
INTERFACE ASSOCIATES, Laguna Niguel, CA 2004 – 2005
Development Engineer
Tested a novel process that was used to develop a new product used for angioplasty, a
polyurethane catheter balloon. Performed tasks that helped the manufacturing room to reach ISO
9000 certification.
• Led a $10M project to design a process to create nylon and polyurethane 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.
DUPONT, Wilmington, DE 2002 – 2004
Engineering Mechanics (Summer Internship)
Built models and performed finite elemental analysis that reduced costs by guiding process plants on
appropriate methods to deal with structural failures.
• 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 customers to find
solutions to prevent catastrophic mechanical failures.
EDUCATION
MBA, Cross Continent Program, Duke University, The Fuqua School of Business, Durham, NC,
Projected Graduation: December 2011, GPA: 3.5
Concentration: Health Sector Management, HSM
Courses: Financial Accounting, Managerial Effectiveness, Decision Models,
Managerial Economics, Statistical Models, and Marketing Management
MS, Biomedical Engineering, Purdue University, West Lafayette, IN, 2007, GPA: 3.7
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
BS, Mechanical Engineering, Virginia Tech, Blacksburg, VA, 2004, GPA: 3.3
Senior Design Project: Hydrogen powered hybrid electric vehicle,
controls and heat transfer development
COMMUNITY INVOLVEMENT
Big Brothers & Big Sisters, Volunteer
Cross Creek Lakes Home Owners Association, Chairman and Activities Manager
Duke University HSM Class Representative
