Sarah Paro

Sarah Paro

Senior Quality Engineer-Zimmer Hip New Product

Location
Warsaw, Indiana (Fort Wayne, Indiana Area)
Industry
Medical Devices

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Sarah Paro's Overview

Current
  • New Product Development Senior Engineer-Quality at Zimmer
Past
Education
Connections

500+ connections

Sarah Paro's Summary

Motivated engineer with a passion for developing new medical technology and improving the quality of life of others. Actively seeking development and quality opportunities in the medical device field. Experience working in manufacturing facilities and new medical device engineering. Directly supported the manufacturing and development of Quality System processes. Stimulates teamwork while actively participating as a leader. Always provides top quality work output.

Specialties: Class II & III Medical Devices, DHF Remediation, traceability matrices, risk analysis

Sarah Paro's Experience

New Product Development Senior Engineer-Quality

Zimmer

Public Company; 5001-10,000 employees; ZMH; Medical Devices industry

May 2011Present (3 years 5 months)

• Submitted internal patent application on a new cutting tool to improve Operating Room efficiency and accuracy
• Lead development efforts on FDA 21 CFR 820 Design History File (DHF) Remediation
• Actively engaged surgeon/user feedback on designs through hands on cadaver labs to improve human factors
• Developed Gantt charts, resource plans and financial plans to meet aggressive budgets and timelines
• Developed test and validation protocols that involved new supplier processes
• Initiated/completed complaint investigations for implants/instruments, including Medical Device Reports (MDRs)
• Participated actively in FDA audit activities
• Created inspection plans to improve product quality
• Developed statistical sampling protocols to release product to the field
• Served as Subject Matter Expert for Gage Repeatability and Reproducibility (Gage R&R) Studies
• Developed process improvement for change management system to provide better device traceability
• Performed a gap assessment of quality systems for combination products for both FDA and E.U. requirements
• Served as a Corrective and Preventive Action (CAPA) Engineer to aid teams in performing root cause analysis, investigation, implementation and Verification of Effectiveness (VoE)

Masters Student

Purdue University

Educational Institution; 10,001+ employees; Higher Education industry

August 2011May 2013 (1 year 10 months) West Lafayette, IN

-Master of Science in Interdisciplinary Engineering
-Specialty in Biomedical Engineering
-Tissue design project using cell sheet technology and a thermopolymer to treat superficial partial thickness burns while reducing the risk of infection . Modeled the regulatory and development pathway to take this product to market.

Quality Engineer-Knees

Zimmer

Public Company; 5001-10,000 employees; ZMH; Medical Devices industry

January 2011May 2011 (5 months)

Quality Engineer Coop

Zimmer

Public Company; 5001-10,000 employees; ZMH; Medical Devices industry

July 2008October 2010 (2 years 4 months)

Worked with surgeons to conduct cadaveric studies resulting in improved instrument and implant designs. Updated Measurement Instruction Sheets (MIS) by providing feedback for current gaging techniques through gage studies to improve manufacturing processes. Updated product MIS for FDA Class III devices for gender knees. Initiated and revised Standard Operating Procedures (SOP) and Visual Aids for Manufacturing inspections and Quality controls which improved processes. Developed test protocols for Gage R&R tests that provided feedback for Quality Plans and Manufacturing Inspections for implantable devices. The Gage R&R tests were used in multiple departments as a process control parameter to reduce time in implementing quality plans.

Kosciusko Home Care and Hospice Volunteer

Oakwood Hospital and Medical Center

Nonprofit; 5001-10,000 employees; Hospital & Health Care industry

January 2010July 2010 (7 months)

Assisted patients and families in end-of-life care and support. Trained in Health Insurance Portability and Accountability Act (HIPPA) regulations and gained familiarity with patient home medical devices.

Educational Institution; 501-1000 employees; Higher Education industry

20062010 (4 years)

-Major in Mechanical Engineering
-Minor in Biochemistry
-Specialty in Bioengineering Applications
-Senior Capstone Project to design a medical device to aid patients through the range of motion from standing to sitting

Thesis Student

Kettering University

Educational Institution; 501-1000 employees; Higher Education industry

20062010 (4 years)

-Senior Thesis titled "Measurement Systems Analysis for Orthopedic Implants"
- "Outstanding Thesis Award" for Senior Thesis

Research Engineer Co-op

Ford Motor Company

Public Company; 10,001+ employees; F; Automotive industry

July 2006June 2008 (2 years)

Designed and implemented electrical and mechanical anode and blower tests stands for hydrogen fuel cell research. These test stands were used for development of new hydrogen fuel cell vehicles. Documented road testing data of fuel cell vehicle performance partially funded by the Department of Energy.

Sarah Paro's Courses

  • MS/MSE, Biomedical Engineering

    Purdue University

    • Tissue Engineering (BME55100)
    • Kinematics and Dynamics of Human Motion (BME 59500)
    • Regulatory Compliance for Biomedical Devices (BME 59500 )
    • Regulatory Issues Surrounding Approval of Biomedical Devices (BME 59500 )
    • Linear Algebra with Applications (MA 51100)
    • Quantitative Physiology (BIOL 59900)
    • Biomedical Engineering Ethics (BME 59500)

Sarah Paro's Skills & Expertise

  1. DFMEA
  2. Medical Devices
  3. GD&T
  4. FDA
  5. Minitab
  6. Validation
  7. V&V
  8. Biomedical Engineering
  9. Quality System

Sarah Paro's Education

Purdue University

MS/MSE, Biomedical Engineering

20112013

Kettering University

Bachelors, Mechanical Engineering Major, Biochemistry Minor, Bioengineering Specialty

20062010

Graduated Summa Cum Laude in December 2010.

Activities and Societies: Society of Women Engineers Member, Vice President of Scholarship for Alpha Gamma Delta Fraternity for Women, President of Pre-Med Club, Professional Leadership Honor Society, President of Kettering's Dance Club, Student Government

Sarah Paro's Additional Information

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