Senior Biomedical Engineer

California Radiographics, Inc.; Phoenix (AZ); On-site; USD 110,000 - 170,000; Full time

Job summary

California Radiographics, Inc. in Phoenix, AZ seeks a Senior Biomedical Engineer to troubleshoot MRI/CT/PET systems, lead installations, and ensure FDA/ISO13485 compliance. You will perform FMEA/RCA analyses, coordinate with hospital IT and radiology teams, and develop CAD parts with SolidWorks.

The role requires a Bio-Medical Engineering degree and strong problem-solving skills, with readiness for 24/7 remote support when needed.

Qualifications

• Bachelor's degree in Bio-Medical Engineering or Bioengineering required.
• Experience in diagnostic imaging systems (MRI/CT/PET) a plus.
• Ability to lead installation projects and ensure regulatory compliance.

Responsibilities

• Troubleshoot software and hardware issues in diagnostic imaging systems.
• Perform quality checks to meet FDA/ISO13485/ACR requirements.
• Lead installation, testing, and validation for MRI, CT, and PET CT systems.
• Conduct FMEA and RCA analyses and implement corrective actions.
• Configure hospital networks and coordinate with IT and radiology teams.
• Develop CAD parts and fixtures; 3D print as needed.
• Provide 24/7 remote support and document service activities.

Skills

Troubleshooting

Diagnostics

FMEA/RCA

System integration

Cross-functional coordination

Python

C programming

Linux

Team leadership

Education

Bachelor's Degree in Bio-Medical Engineering or Bioengineering

Tools

SolidWorks

CAD software

3D printing (SLA/FDM)

Windows/Linux

Salesforce CRM

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Biomedical Engineer

Phoenix, AZ, US

3 days ago Requisition ID: 1814

Sr. Biomedical Engineeris needed to perform the following duties

Troubleshooting software and hardware issues in diagnostic medical imaging systems (MRI, CT, and PET)

• 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 result.
• 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 ACR requirement.
• 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 and several other sensors as needed. 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 Salesforce.
• 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.

Bachelor's Degree is required inBio-Medical Engineering or Bioengineering