ROBERT VILLANO

ROBERT VILLANO
45 Quail Run, Long Valley, N.J 07853 | H: 908-979-3185 | C: 862-432-0326 | rvillano1000@gmail.com

Profile
I possess a very strong background in both mechanical and electrical engineering. I am a (SME) Subject Matter Expert
in Risk Management Activities predicated on ISO standards 14971,9001 and 13485. I have extensive experience in the fields of
reliability engineering, failure analysis, HALT analysis, test engineering and design engineering. I am responsible for
the creation of DFMECA’s, Risk Analysis, Risk Management Plans, Risk Management Reports as well as statistical
analysis, and design reviews. As a highly productive achiever with strong interpersonal skills, I have consistently
demonstrated my ability to lead team members and initiate, develop and successfully complete projects on time. I am
extremely motivated, loyal and a team player who has the ability to make others around him more productive.
Skills
Project Management RoHS2
Electro-Mechanical design Failure Analysis trending/Fault Tree Analysis
Risk Management Sr. CAPA committee member
Reliability Verification testing HALT/HASS Analysis
Team player Agile electronic documentation system
Shock and vibration testing
21 CFR 820
Accomplishments

Liaised with design group to modify and improve overall product performance.
Eliminated product defects and enhanced reliability through proven statistical techniques.
Performed data collection and statistical analysis that resulted in sound recommendations that were adopted by
department.
Testing, Evaluation and Analysis:
Tested equipment to ensure compliance.
Analyzed data and provided recommendations which resulted in adoption of new cost-saving equipment.
Initiated RoHS2 program
Quality Control:
Saved money on supply costs by working closely with suppliers to ensure components met departmental and
medical industry quality standards.
designed and built test specific electro-mechanical test fixtures to more accurately test products

Professional Experience
Reliability Engineering Manager 01/2005 to 08/2015
Biomet Parsippany, N.J
Manages Reliability Engineering and Failure Analysis personnel
• Inspects completed work of direct reports and test related documentation
• Establishes objectives for individual team members to align with company goals and objectives
• Insures that ZimmerBiomet complies with regulatory agencies and notified bodies with respect to industry safety
standards within the US and internationally.
• Develops both project and yearly team budgets
• SME (Subject Matter Expert) for Risk Management during FDA Audits
• Troubleshoots and offers technical guidance on complex issues
• Primary reviewer for the Reliability Engineering dept., for all design documentation through the Agile electronic
documentation system.
• Created verification testing guidelines for FDA class III medical devices using IEC, ANSI, AAMI, ISO, EEC, EN, MIL,
and UL standards
• Provides engineering support for all manufacturing related difficulties

• Provide technical input on new designs based on passed field issues.
• Well established relationship with certified test facilities (ETL, UL, TUV, NAMSA , Met Labs)
• RoHS2 team
• Recommends product design changes based on reliability testing or regulatory agency requirements
• A senior CAPA committee team member
Engineering Manager – Failure Analysis 04/2000 to 02/2005
Biomet Parsippany, N.J
Directly managed the (8) eight team member Failure Analysis dept.’s daily activities
• Review and approve failure analysis technical reports.
• Provides yearly objectives for individual team members to align with company goals.
• Coordinated corrective efforts with manufacturing facility when issues surfaced
• Develops both project and yearly team budgets
• Troubleshoots and offers technical guidance on complex issues to design team.
• Reviews all Engineering, Testing, and Manufacturing design documentation through Agile such as (FMECA’s, Risk
Hazard Analysis’s, Weekly Failure Reports, VERP’s, VERR’s, CAN’s, CAPA’s, and Trending Reports)
• Provides verification testing guidelines for FDA class III medical devices using IEC, ANSI, AAMI, ISO, EEC, EN, MIL,
and UL standards
• Provides engineering support for all manufacturing related activities
• Provide technical input and corrective actions in regards to product failure trending data
• Well established relationship with certified test facilities (ETL, UL, TUV, NAMSA, Met Labs )
• Professionally responded to field calls from patients/customers with device usability issues as well as technical
inquiries.
• Recommends product design changes based on failure analysis and HALT testing
• Provided failure analysis trending charts at CAPA meeting using Microsoft Excel
Senior Reliability Engineer 05/1995 to 03/2000
Electro-Biology Inc (EBI Parsippany, N.J
Directs and supports other engineers with the Reliability dept.
• Inspects completed work of direct reports
• Establishes objectives for individual team members
• Prioritizes tasks for individual team members
• Insures that EBI complies with regulatory agencies, national and international (European Union)
• Conducts all verification activities for new designs
• Writes and approves technical reports for all verification activities
• Designs and directs the building of electrical and mechanical test fixtures and test systems to support new product
Manufacturing
• Reviews, revises and approves manufacturing work instructions through the Agile electronic documentation system.
• Initiates and/or approves engineering changes through the ECO / DCR process which improve the performance,
reliability or manufacturing process of product designs
• Write engineering documents such as specifications, reports, bills of materials and protocols and reports
• Recommends product design changes based upon new safety requirements, reliability testing and regulatory agency
Requirements.

Education and Training
Associate of Science: Electronic Engineering Technology
RETS Electronic School Nutley, N.J, USA
Continuing education: Electrical Engineering
Essex County College Newark, N.J, USA
Affiliations

CAPA committee member