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Alfred E. Mann Institute
Open Positions, February 14, 2006
Exempt
- Grade TM
- Computer Systems Engineer, Senior (JC 167511), Req. 18326
- The Alfred E. Mann Institute for Biomedical Engineering
- The Alfred E. Mann Institute for Biomedical Engineering (AMI) is a university affiliated medical device development organization. AMI is currently seeking a Systems Engineer with a strong background in Electronics. The ideal candidate will contribute to all software development including requirements, formulation, feasibility, design, build, integration, validation, verification, testing and implementation for medical devices. This individual will work closely with management and the Senior Systems Engineer to capture and implement systems requirements. They will also lead the efforts of other staff engineers in overall software system design, verification and validation for building device prototypes, and where necessary, devices that can be used for clinical studies. The incumbent will assist and manage device design, development and validation consonant with FDA regulations for medical devices. Coordinate, with the Project Manager, and lead engineering efforts for assigned projects. Lead software development aspects of each assigned project. Coordinate, with the Quality Systems Manager, the maintenance of all AMI and FDA required documentation for software development. In addition, the incumbent will apply electrical and computer engineering principles in planning, coordinating and executing research and development activities. Contribute to development of state-of-the-art technology. Develop innovative solutions to complex engineering problems. Writes technical reports and publishes technical papers and articles. Minimum qualifications: Demonstrated ability to learn and implement software development platforms. Prior knowledge and experience with FDA medical device requirements and cGMPs. Minimum five years of experience in device development (medical device development preferred). Prior experience as a lead/project engineer.
- Grade TJ
- Electronics Hardware Engineer (JC 167311), Req. 18327
- The Alfred E. Mann Institute for Biomedical Engineering
- Seeking an individual to support the research, design and development of prototype and limited production electronic hardware required for ISI research projects. The ideal candidate will identify and access quality assurance problems and implements. Use knowledge of clinical and FDA regulations to guide clinical field testing and medical product accountability. The incumbent will handle all phases of prototype design including: *design and capture of circuits using a CAE/CAD workstation; *design simulation and fault isolation; *design verification and test, include design of test adapters and writing test plans. Performs initial layout floor planning. Creates bill of material and initiates parts orders. Create and maintain design documentation for originals and revisions. In addition, the incumbent will provide support for limited production runs of modules. Coordinate vendor services and performs some assembly work. Write reports on experimental and developmental results. Minimum qualifications: Bachelor’s Degree with one year experience; however, combined experience/education as substitute for minimum education. Knowledge of Electronic Test Equipment such as oscilloscope, logic analyzer, signal generators meters and test systems required. Master’s degree in Engineering preferred. Master’s degree in Regulatory Science highly desirable (or experience in Quality assurance).
- Grade HG
- Clinical Project Manager (JC 135107), Req. 18330
- The Alfred E. Mann Institute for Biomedical Engineering
- Seeking an individual to assist with formulating research objectives, contribute to design of research protocols, oversee clinical research trials, conduct quality assurance reviews. Diagnose patient complaints and performs treatments according to established protocols or as prescribed by a physician. May develop course curriculum and teach students clinical topics. Manage staff, develop and manages budgets, participate in contract and grant administration. The ideal candidate will use knowledge of clinical and FDA regulations to guide clinical field testing and medical product accountability. Handle prototype design, including design verification and test. Provide support for limited production runs. The incumbent will assist a principal investigator with formulating research objectives. Plan, organizes and schedules activities to meet objectives. Develop and implement operating policies, procedures and systems to support planned operations. Ensure these are well-documented and communicated to project personnel. Contribute to the design of research protocols. Evaluate, recommends and implements procedures for data acquisition, management and quality control. Evaluate and recommends statistical methods for data analysis and monitors and interprets results of analysis. Prepare technical reports and papers on study plans, progress and results of research activities. In addition, the incumbent will conduct quality assurance reviews of research protocols. Monitor and cites violations and submits regular reports.
THIS POSITION IS CURRENTLY LOCATED ON THE HEALTH SCIENCES CAMPUS. Minimum qualifications: Bachelor’s Degree with five years experience. Degree plus postgraduate certification/licensure in specialized clinical field. Current BCLS certification. Patient care and teaching experience. Familiarity with JCAHO requirements. Experience in conducting clinical research trials. Master’s degree in Engineering preferred. Master’s degree in Regulatory Science highly desirable (or experience in Quality Assurance). Knowledge of Electronic test equipment such as oscilloscope, logic analyzer, signal generators meters and test systems highly desired.
- Seeking an individual to assist with formulating research objectives, contribute to design of research protocols, oversee clinical research trials, conduct quality assurance reviews. Diagnose patient complaints and performs treatments according to established protocols or as prescribed by a physician. May develop course curriculum and teach students clinical topics. Manage staff, develop and manages budgets, participate in contract and grant administration. The ideal candidate will use knowledge of clinical and FDA regulations to guide clinical field testing and medical product accountability. Handle prototype design, including design verification and test. Provide support for limited production runs. The incumbent will assist a principal investigator with formulating research objectives. Plan, organizes and schedules activities to meet objectives. Develop and implement operating policies, procedures and systems to support planned operations. Ensure these are well-documented and communicated to project personnel. Contribute to the design of research protocols. Evaluate, recommends and implements procedures for data acquisition, management and quality control. Evaluate and recommends statistical methods for data analysis and monitors and interprets results of analysis. Prepare technical reports and papers on study plans, progress and results of research activities. In addition, the incumbent will conduct quality assurance reviews of research protocols. Monitor and cites violations and submits regular reports.
Non-exempt
No positions available.
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