Malhar Shah Email & Phone Number

Boulder, Co

• Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety, and effectiveness of medical devices. Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury.• Interacts with multiple departments within Medtronic - MITG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.• Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.• Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.

Boulder, Co

• Evaluate, analyze, and provide trending data on all the incoming complaints information; maintain records in the electronic database and detect trends in the complaints.• Determine complaint reportability to both government and Medtronic internal agencies; ensuring record documentation is retained in a constant state of audit readiness per internal policies.• Communicate and liaise with Manufacturing and Engineering, Technical Service, Failure Investigation, Research and Development, and Quality Assurance within Medtronic and with customers for complete and comprehensive complaint processing.• Providing basic technical expertise and assistance in handling complaints to comply with current FDA and international reporting regulations.• Review and interpret risk management documentation as it applies to the complaint event.• Determine the failure analysis for the relevant complaint mode to ensure compliant reporting.

Lowell, Massachusetts

- Graded weekly assignments of the course ‘Introduction to Biomedical Engineering and Biotechnology (IB 500)’ for undergraduate and graduate students.- Assisted students with their problems.

Managed day to day store operations including managing inventory.Working on cash register.

India

Experienced servicing on imaging products mainly Ultrasound and different health care products such as the patient monitor, ventilator, defibrillator and on ECG machine. Mainly held the troubleshooting of all the mentioned products.Attended medical electronics equipment installation, repairs and carried out planned maintenance. Handled part logistics, ordered and return part accessories and raised purchase orders, maintained stock inventories. Handled customer queries.Attended different training and seminars for detailed knowledge of a device and their troubleshooting. Also experienced hands-on training on the specific instrument.Provide assistance to clinical staffs and doctors with their queries and provide an effective solution.Assist the sales team by providing them the overview about some device like ECG, Patient Monitor.

Master'S Degree, Biomedical Engineering And Biotechnology, 3.90/4.00

Activities and Societies: Ballroom Dance, Badminton, Cultural ActivitiesPursuing my master degree with specialization.

Master Of Science (M.S.), Biomedical Engineering And Biotechnology, A

Bachelor Of Technology (B.Tech.), Biomedical/Medical Engineering, 8.00/10.00 Cgpa Or 3.75/4.00 Gpa

Activities and Societies: Annual events, Conference on Indian Medical Devices & Plastics Disposables Industry, different college events.

Higher Secondary Certificate, Higher Education/Higher Education Administration

Studied higher secondary subjects: Physics, Chemistry, Mathematics, English & Computer

Attended Xi Standard, Higher Secondary Education

Secondary School Certificate, Secondary Education And Teaching

Activities and Societies: Annual Functions, different sports events, cricket tournaments, Singing and dancing.Studied Secondary Education..