Vijay Kumar S Email & Phone Number

Chennai, Tn, In

Chennai, Tamil Nadu, India

Function: Sr.Biomedical Engineer - QA.Equipment tested and qualified: BD Infusion Pump, Syringe pump, C-ARM X-Ray Imaging, Ventilator.Work directly with the client, gathering requirements to analyze and implement technology upon the premises, which include assisting with clinical trials, development, system configuration, implementation, and support of assigned applications for the organization.Defining and following the troubleshooting techniques and preventive-maintenance SOPs as recommended in the DFU/manuals and to satisfy IEC standards (60601-1, -24), ISO 13485, and ISO 14971.Identify risks and address gaps between existing processes and new requirements.Prepare an installation and qualification report, an inspection report, and support for the clinical trial test protocol.Preparing safety tests for medical equipment and the healthcare environment in order to ensure the safety of patients and staff from electrical or mechanical hazards.Time-motion study and cost-saving purpose, and coordinate with the onsite team to complete tasks on time.

Bengaluru, Karnataka, India

Function: Sr.Biomedical Engineer Equipment tested and qualified: ESWL, LASER, LITHOCLAST.Calibration of equipment at scheduled intervals, troubleshooting, and repair of malfunctioning equipment.Initialize and qualify the new equipment by conducting test protocols at standard operating conditions and fine-tuning codes for modifications as required.Install, configure, and manage the infrastructure for System Center Configurations Manager (SCCM), and configure security patching for medical devices.Maintain special equipment service lists, evaluate service contracts, and maintain critical equipment spare inventories.Handling meeting with Customer for every milestone stages, and getting approval from customer through presentations.Product Validation /Evaluation /Reliability/ Functional & System safety for testing and qualifying Products & Process, Report creation, Closely worked with RSO, for developing technology, Product evaluation & the System requirements into proven functions with the right quality within minimum time and with cost effective solutions. Being a Cross functional team member, Work with team to resolve the Customer complaint handling /Process defect/ Post market survey and suggesting Root-Cause for improvements of product.

Arunachal Pradesh, India

Function: Bio-medical EngineerEquipment tested and qualified: CT Scan, C-ARM X-Ray Imaging, Ultrasound.Installs,tests,calibrates and repairs biomedical equipment;train users and maintains operations to aid in patient diagnosis and treatment.Completes preventative maintenance schedules,conducts tests and troubleshoots and repairs fault to keep things running smoothly order.Makes service calls for specialized equipment,reviews service contracts and keep track of equipment inventory. Directs the use of biomedical equipment by conducting demonstration,training other clinical staff in the use and care of the equipment and answering queries.Improves equipment performance by analyzing machine- patient interactions, consulting with users,proposing improvements and coordinating with manufacturers.Checks stock, anticipates needs, places and expedites purchases and verifies receipt to keep supplies inventory up to date.Collects, analyses and summarizes information and trends to prepare biomedical reports. Maintains correct documentation of biomedical equipment and ensures equipment quality according to medical standards.Conducts safety testing,recommends and follows procedures,trains and guides medical and healthcare personnel and follows codes to ensure a healthy and safe working environment.Maintains a documented procedure for disposal of equipment. Equipment procurement/condemnation/Preventative and breakdown maintenance/Calibration of equipmentTurn around time for responding to complaints or service requests.

Salem

Function: Bio-medical Engineer(Deputed@ X-rays)Responsible for change control assessment from regulatory perspective and timely reporting of post approval changes to respective regulatory authorities.Making Initial conceptual design (Case studies & Analysis) of the product and building prototypes & MBD models for concept proof of design requirements through different phases of design process.Prepare labeling and package requirements based on the regulatory standards.Hands on experience in Electronics parts selection, Specifications, Design aspects, Testing requirements, PCB layout, Soldering skills, Soldering joint inspection skills.Interacts with regulatory agency personnel in order to expedite approval for regulation certifications.Hands on experience in High Power & High Frequency product features testing for C-ARM, Mobile X-Ray CT machines & applications.Driving cross functional team, for technical guidance & to resolving Customer complaints and adhere the EMC, ISO requirements, and FEMA (Failure Mode Effect Analysis).Maintaining Engineering change management (ECR) activities and Design history files.Writing test protocols, Design Controls, PPAP,DFMEA, DVP and SOP for Assembly and Manufacturing process with respect to ISO requirements.Lead continuous improvement activities by driving strategically and implementation of process and product quality improvement initiatives and supporting Engineering trials.