Cameron_Carroll_Resume
1
Cameron S. Carroll M.S. 40 Sunol St. Apt. 6 San Jose, Ca 95126 • 559.392.5721 • c[email protected] Career Summary Current St. Jude Medical Technical Services Engineer and accomplished biomedical engineer who is seeking to further my career in the cardiovascular technology industry. Professional Expertise Includes: Providing technical support and knowledge in regards to EP, Brady, and Tachy St. Jude Medical products. Ability to make complex FDA reportability decisions in regards to device malfunctions and patient adverse events. Experience in areas of medical research including medical device testing and animal research. This includes performing experiments, collecting data and analyzing data to determine significant statistical results. Professional Experience Technical Services Engineer I, Post Market Surveillance, St. Jude Medical, Sunnyvale, CA 2013-Present - Triage and review medical device complaints in regards to ICD and high voltage SJM products based on FDA reportability criteria, complaint severity levels, and adverse health outcomes to the patient. - Provide leadership support to the product surveillance team in all the roles I perform and act as a mentor to newer and fellow triagers, coordinators, initiators, and reviewers. - In charge of determining the reportability of patient deaths in regards to CRM products. - In charge of the final review of death MDRs (Medical Device Reports) for the department before submission to the FDA. - Employ technical writing skills to edit complaint event descriptions and determine if the descriptions are technically accurate in regards to cardiovascular physiology and the specific SJM product specifications. - Evaluate Reliability Lab failure analyses and write formal letters to doctors who request findings of device testing. - Use a combination of personal technical knowledge, SOPs, DWIs, MDR rationales, EGMs, medical records, FCRs from technical services, Adverse Event Report Forms, Death Reports to PIB, and field resources to determine the root cause of adverse events and malfunctions related to CRM devices. - Follow up with SJM field personnel and healthcare workers to determine the FDA reportability of complaints that have incomplete information or are considered unknown in origin. - Provide technical training presentations to the Product Reporting Team based on gaps in coworker knowledge and newly approved product specifications. Presentations include Pace/Sense and High Voltage ICD Vectors; the Non-Sustained Lead Noise algorithm; and the latest functions of the new Ellipse and Assura ICD family of devices. - Complete, as a team, the triaging of approximately 2000 complaint records on a bimonthly basis. - Oversee SharePoint intranet site by uploading relevant documents and efficiently organizing the site for ease of use. Microfluidic H-Filter Team Leader 2011-2013 - Led a Biofluidic’s lab team in the research, design, manufacturing and testing of a novel microfluidic device. - Created CAD and COMSOL models of the the device to simulate fluid flows and electrical forces on analytes in blood. - Designed validation experiments to test the efficacy of the device in separating albumin from a blood sample. - Publication: “A Microfluidic Pretreatment Isoelectric Focusing DC-Field Assisted H-Filter for the Separation of Charged Particles”, Cal Poly Digital Commons, March 2013 Mouse Hindlimb Ischemia Surgery Study Member 2011-2012 - Performed sterile surgery on the murine hindlimb to research the effects of ischemia on muscle force production. - Performed incisions, ligations of the femoral artery, cell transplant treatments, and suturing of the incision. - Analyzed data of force production measurements between ischemic and non-ischemic hindlimbs and presented findings. Education California Polytechnic State University, San Luis Obispo, CA - Master of Science Degree in Biomedical Engineering 2011-2013 - Bachelor of Science Degree in Biomedical Engineering 2007-2011 - Relevant Coursework: FDA (and International) Medical Device Approval, Bioelectronics, Microcirculation, Medical Imaging, Bioseparations, Microfluidics, Biomaterials, Cell Transplantation and Biotherapeutics, Anatomy and Physiology *Excellent References upon Request
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C a m e r o n S . C a r r o l l M.S. 40 Sunol St. Apt. 6 San Jose, Ca 95126 • 559.392.5721 • [email protected]
C a r e e r S u m m a r y
Current St. Jude Medical Technical Services Engineer and accomplished biomedical engineer who is seeking to further my career
in the cardiovascular technology industry.
Professional Expertise Includes:
Providing technical support and knowledge in regards to EP, Brady, and Tachy St. Jude Medical products.
Ability to make complex FDA reportability decisions in regards to device malfunctions and patient adverse events.
Experience in areas of medical research including medical device testing and animal research. This includes performing
experiments, collecting data and analyzing data to determine significant statistical results.
P r o f e s s i o n a l E x p e r i e n c e
Technical Services Engineer I, Post Market Surveillance, St. Jude Medical, Sunnyvale, CA 2013-Present
- Triage and review medical device complaints in regards to ICD and high voltage SJM products based on FDA reportability
criteria, complaint severity levels, and adverse health outcomes to the patient.
- Provide leadership support to the product surveillance team in all the roles I perform and act as a mentor to newer and
fellow triagers, coordinators, initiators, and reviewers.
- In charge of determining the reportability of patient deaths in regards to CRM products.
- In charge of the final review of death MDRs (Medical Device Reports) for the department before submission to the FDA.
- Employ technical writing skills to edit complaint event descriptions and determine if the descriptions are technically
accurate in regards to cardiovascular physiology and the specific SJM product specifications.
- Evaluate Reliability Lab failure analyses and write formal letters to doctors who request findings of device testing.
- Use a combination of personal technical knowledge, SOPs, DWIs, MDR rationales, EGMs, medical records, FCRs from
technical services, Adverse Event Report Forms, Death Reports to PIB, and field resources to determine the root cause of
adverse events and malfunctions related to CRM devices.
- Follow up with SJM field personnel and healthcare workers to determine the FDA reportability of complaints that have
incomplete information or are considered unknown in origin.
- Provide technical training presentations to the Product Reporting Team based on gaps in coworker knowledge and newly
approved product specifications. Presentations include Pace/Sense and High Voltage ICD Vectors; the Non-Sustained Lead
Noise algorithm; and the latest functions of the new Ellipse and Assura ICD family of devices.
- Complete, as a team, the triaging of approximately 2000 complaint records on a bimonthly basis.
- Oversee SharePoint intranet site by uploading relevant documents and efficiently organizing the site for ease of use.
Microfluidic H-Filter Team Leader 2011-2013
- Led a Biofluidic’s lab team in the research, design, manufacturing and testing of a novel microfluidic device.
- Created CAD and COMSOL models of the the device to simulate fluid flows and electrical forces on analytes in blood.
- Designed validation experiments to test the efficacy of the device in separating albumin from a blood sample.
- Publication: “A Microfluidic Pretreatment Isoelectric Focusing DC-Field Assisted H-Filter for the Separation of Charged
Particles”, Cal Poly Digital Commons, March 2013
Mouse Hindlimb Ischemia Surgery Study Member 2011-2012
- Performed sterile surgery on the murine hindlimb to research the effects of ischemia on muscle force production.
- Performed incisions, ligations of the femoral artery, cell transplant treatments, and suturing of the incision.
- Analyzed data of force production measurements between ischemic and non-ischemic hindlimbs and presented findings.
E d u c a t i o n
California Polytechnic State University, San Luis Obispo, CA
- Master of Science Degree in Biomedical Engineering 2011-2013
- Bachelor of Science Degree in Biomedical Engineering 2007-2011
- Relevant Coursework: FDA (and International) Medical Device Approval, Bioelectronics, Microcirculation, Medical Imaging,
Bioseparations, Microfluidics, Biomaterials, Cell Transplantation and Biotherapeutics, Anatomy and Physiology
*Excellent References upon Request
