Sr. Biomedical Engineer

626•Las Vegas, NV

About The Position

Founded by Philip Revien and Michael Fischer in 2014, 626 provides maintenance expertise on all medical technology equipment manufacturers and modalities. Philip and Michael first met in the maternity ward of a South Florida hospital on June 26, 2012, the day each of their sons were born. The vision for 626 (a tribute to their sons’ birth dates) was also born that day. The pair began talking and soon realized they shared a common goal— improving patient care. Two years later, 626 was established. What began as two men in a garage, 626 now employs more than 100 employees nationwide and has emerged as one of the fastest-growing third-party company in the healthcare technology management market. is needed to perform the following duties:

Requirements

Bachelor's Degree is required in Bio-medical Engineering or Bioengineering

Responsibilities

Troubleshooting software and hardware issues in diagnostic medical imaging systems (MRI, CT, and PET).
Performing scheduled preventative maintenance that includes calibrations and verifications of system according to OEM specifications.
Performing quality checks needed to meet the ACR, FDA and ISO 13485 requirement for diagnostic image quality of the patient.
Identifying the system components causing image artifacts and inappropriate functioning of the scanner.
Producing corrective actions that are cost-effective and efficient to stop the reoccurrence of the issue.
Monitoring the effectiveness of the corrective actions by testing and analyzing the results.
Conducting analysis and investigations using Failure Mode and Effect Analysis (FMEA) and Root Cause Analysis (RCA).
Replacing the required components in the system, calibrating and fine tuning the system to optimize the performance of the system.
Ensuring parts replaced are in compliance with FDA and ISO 13485 regulations.
Setting up communication between MRI, CT, and PET CT and hospital network system by configuring network nodes, IP address and AE title.
Debugging and analytical troubleshooting operating software (Microsoft Windows/Linux) in workstations and image reconstruction system (C-programming and Python).
Providing 24/7 remote Tech support to the system technologists and colleagues in a time constraint environment to effectively reduce the system downtime.
Helping the remote analysis team by writing programming codes (C-programming and Linux) to extract critical parameters for monitoring the system and preventing potential problems.
Leading the installation project of CT, MRI, and PET CT in hospital, ER, diagnostic center and warehouse.
Performing system and site inspections before getting contracts to evaluate the condition of the system.
Analyzing the procured systems with respect to company quality standards.
Reporting and providing feedback to the Mangers and Sales Managers regarding the valuation and condition of the system.
Verifying if the system is performing according to OEM specification after installation.
Producing constructive and technical solutions that meet FDA, ISO 13485 and ACR requirement for installation of the equipment.
Setting up and testing MRI pulse sequence protocols according to Radiologists and Technologist requirement.
Collaborating with Hospital IT team for IP address changes and configuring new networks.
Designing necessary parts and fixtures required for the equipment installation using CAD software such as Solidworks.
3D printing parts using SLA and FDM 3d printer.
Manufacturing parts using power tools such as drills, lathe, and saw machine.
Finding and coordinating with machining shops in cases where special manufacturing methods are required.
Co-ordinating with electrical repair technicians to track the history of non-functional CT, MRI, and PET CT parts and planning the corrective actions while adhering to FDA and ISO 13485 regulations.
Installing, evaluating, and verifying repaired parts.
Preparing test documents that meet ISO 13485 and 21 CFR Part 11 (electronic document and signature) requirements which contains the list of tests performed to verify the functioning of the part and the final test
Maintaining and operating all CT, MRI, and PET CT equipment in the lab and warehouse which are used for testing and verifying repaired parts and make sure all of them are performing under OEM specifications and
Designing necessary parts and fixtures required for the part repair using CAD software such as Solidworks.
3D printing and manufacturing the designed parts.
Designing various monitoring devices for the system by writing code on Python implementing on Arduino by using different kinds of sensors such as temperature sensor, pressure sensor, hall effect sensor, IR sensor
Communicating with medical staff and radiology managers, providing technical information and regular updates about the system.
Analyzing status of the system and recommending radiology manager for modifications and upgrades needed.
Educate/train radiologist and technician for proper use of the equipment.
Training new employees in understanding physics of CT, MRI, and PET CT.
Providing direct training to new employees in troubleshooting and maintenance of CT, MRI, and PET CT.
Accurately documenting all service activities in accordance with the Company Quality Standards and submitting service reports in a timely manner using Customer Relationship Software (CRM); Saleslogix and
Communicating and coordinating with account manager and service manager with all the service-related activities
Ordering repair parts, timely return of parts and submission of applicable order-related documentation.