42 Sherman Avenue East Newark, NJ - 07029

Paramvir S Sawhney

Phone: 732-915-8952 Email: pvss23@gmail.com

A self motivated Quality engineer with strong technical & problem solving background. Looking for challenging position in medical device, automotive, or aerospace industries. Experience includes Design controls (ISO 13485), Customer communication, Audits, validations, testing & measuring of medical devices, broad knowledge in engineering mechanics, Lean Manufacturing and New Product Development.

Work Experience: Medin Corporation

Medin Corp is a vertical integrated, focused manufacturer of custom and standard class 1 and class 2 sterilization trays. Quality Engineering August 2009-Present Core team member for all phase of product design and release during new product development. Responsible for final review and maintaining of the Device History File (DHF) for every new and existing project (over 50 projects) resulting in better compliance to ISO and FDA regulations. Initiated and led a continuous improvement project resulting in introduction of new silicone cutting methodology thus improving the quality of silicone brackets and reducing the defects. Initiated and established a Statistical Process Control (SPC) on Waterjet machine to monitor and improve the process capabilities. This was the first SPC established on any process in Medn. Handled customer communication to gather and update quality requirements for new projects as well as support current ones resulting in greater customer satisfaction and reduced returns. Collaborated and led multifunctional teams to conduct root cause investigations on CAPA, C-NCR and RMA and verify the effectiveness of implemented corrective and preventive action. Established a new RMA process flow in accordance with ISO requirements and Lean principals resulting in improved turnaround times for returned products and greater customer satisfaction. Responsible for defect note and customer compliant metrics to drive process improvement. Trained various inspectors on use of CMM and Fabrivision machine resulting in 30% reduction in FAI times. Conducted internal audits to insure standard operating procedures comply with ISO and FDA requirements. Responsible for executing validation protocols for various machines and processes. Contributed in developing a new test methodology for new material and supplier qualification. Performed detailed First Article Inspection (FAI) and in process inspection on class 1 and class 2 devices. Manufacturing Programmer Programmed various punch/laser/combo machines using AP-100, Solidworks, Autocad and TruTops. Responsible for programming CMM, Fabrivision 2D laser inspection device used in final inspection process. Responsible for programming and maintaining Waterjet machine used for cutting silicone brackets. Attended Material Review Board (MRB) for disposition of programming and other quality issues.

Zimmer TMT, Inc, Parsippany, NJ

July 2008- May 2009 Engineer Intern Quality Engineering Developed inspection plans to measure the penetration depth of UHMWPE into porous implantable devices. Modeled solutions for Glenoid implant in collaboration with surgeons & engineers. Designed fixtures to hold implants for CMM resulting in 35% reduction in testing times. Conducted FMEA & closed loops between Design History File (DHF) & customer requirement.

UMDNJ-New Jersey Medical School-Department of Orthopaedics

Research Assistant December 2007- June2008 This study was a pilot project for a major Orthopedic company aimed at establishing the stability & pull out strength of locked 3.5mm & 4.5mm tibia plates before they were launched in market. Developed the test protocol according to ASTM standards, performed mechanical testing & statistically analyzed the data.

Education: New Jersey Institute of Technology, Newark, NJ

MS Biomedical Engineering Graduated Summa Cum Laude, GPA: 4.0, Merit Scholar. Punjab Technical University, Punjab, India BS (Hons) Biotechnology Graduated Summa Cum Laude, Merit Scholar. NJIT Provost Scholarship (2007-2008) May 2009 May 2007

Honors:

42 Sherman Avenue East Newark, NJ - 07029 Activities: Member American Society of Quality (ASQ) Graduate Biomedical Engineering Society (GBMES) National Alliance on Mental Illness (NAMI)

Paramvir S Sawhney

Phone: 732-915-8952 Email: pvss23@gmail.com