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Clinical Validation Specialist Resume

Highland Heights, OhiO

CAREER SUMMARY:

  • Clinical Validation Specialist with 7+ years of experience in a Confidential quality and regulatory management system as part of the medical device research and development industry.
  • Experience includes performing integration, verification and validation activities of requirements on Nuclear Medicine and Computed Tomography imaging systems and post processing workstations.
  • Strong background in project planning and reporting, test case development, troubleshooting, testing and auditing of results, product and process, calibration and preventive maintenance of test tools, and maintaining complaint documentation from a regulatory standpoint.
  • Looking to further my knowledge and experience from roles such as a project manager, clinical lead and tester.

PROFESSIONAL EXPERIENCE:

Confidential, Highland Heights, Ohio

Clinical Validation Specialist

Responsibilities:

  • Medical device testing in a Confidential regulated environment while adhering to 21CFR820 and Confidential 60601.
  • Performed integration, verification and validation activities including the following: software installation, test case creation, requirement traceability, testing and auditing of results, product, defect reporting and investigation.
  • Performed project leadership activities including the following: project planning, scheduling of testers and adjusting of project timelines, project reporting, complaint analysis, cross functional program review of deliverables, and process improvement activities.
  • Experience with the following imaging systems: Brightview, Brightview X, Brightview XCT, Gemini TF PET/CT, Gemini TF Big Bore PET/CT, Truflight Select PET/CT, Ingenuity TF PET/CT, Vereos Digital PET/CT, and Ingenuity TF PET/MR.
  • Experience with the following post - processing systems: Extended Brilliance Workspace v1.5-v2.0, IntelliSpace Portal v4.0-v9.0 and XIRIS HIS/RIS.
  • Creation of product and process materials and performing competencies to staff and contractors as the subject matter expert.
  • Project Manager for the following projects: IntelliSpace Portal v5.0 - software upgrade, SRC1 Patch 2 - software upgrade for three Brightview configurations, PRS Database Lockup - software upgrade for eight PET/CT configurations and one PET/MR configuration, Tumor Localization - software upgrade for three Gemini PET/CT configurations and one Ingenuity TF PET/CT configuration.
  • Clinical Validation Lead for the following projects: Vereos PET/CT RfLD and RfVD - first of kind digital PET/CT system.
  • Maintained calibrated tools and phantoms for hot lab and testing use.

Confidential, adecco Highland Heights, Ohio

NM Verification & Validation Contractor

Responsibilities:

  • Medical device testing in a Confidential regulated environment while adhering to 21CFR820 and Confidential 60601.
  • Performed integration, verification and validation activities including the following: software installation, test case creation, requirement traceability, testing and auditing of results, product, defect reporting and investigation.
  • Experience with the following imaging systems
  • Experience with the following post-processing systems Extended Brilliance Workspace v1.5-v2.0 and IntelliSpace Portal v4.0-v5.0.

Confidential, Strongsville, Ohio

Manager of Sales

Responsibilities:

  • Store manager of multiple locations specializing in high volume sales of merchandise.
  • Performed quarterly inspections and inventory of merchandise for $500k stores within the district, including loss prevention reporting.
  • Provided quality customer service and of all staff for multiple stores within the district.

Confidential, Ohio

Computed Tomography Student

Responsibilities:

  • Performed Computed Tomography procedures, including bolus tracking using power injectors, for inpatient, outpatient, emergency room and level 2 trauma patients including pediatrics on the Siemen’s Somatom imaging systems.

Confidential, Brunswick, Ohio

Computed Tomography Student

Responsibilities:

  • Performed Computed Tomography procedures, including bolus tracking using power injectors, for outpatient and emergency room patients including pediatrics on the Siemen’s Somatom imaging system.

Confidential, Cleveland, Ohio

Nuclear Medicine Student

Responsibilities:

  • Performed general Nuclear Medicine and PET/CT procedures, radiopharmaceutical administration and post processing of images for inpatient, outpatient, emergency room and level 1 trauma patients including pediatrics on the Siemen’s Confidential, Siemen’s Symbia, Philips Brightview XCT, Siemen’s Orbiter and Philips Gemini TF PET/CT imaging systems.
  • Additionally, performed radiation therapy planning and staging.
  • Performed Rb82 generator preparation, quality control and elution for Cardiac Perfusion PET/CT imaging.

Confidential, ValleyView, Ohio

Nuclear Medicine Radiopharmacy Student

Responsibilities:

  • Performed Mo99/Tc99m generator quality control and elution for patient dose preparation under the supervision of the Radiopharmacist following sterile techniques and radiation safety procedures.

Confidential, Garfield Heights, Ohio

Nuclear Medicine Student

Responsibilities:

  • Performed Nuclear Medicine procedures, radiopharmaceutical administration and post processing of images for inpatient, outpatient and emergency room patients including pediatrics on the Siemen’s Confidential and Siemen’s Symbia imaging systems.

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