| Duties & Responsibilites : | *LOCAL ONLY
POSITION DESCRIPTION:
*This engineer will lead complaint investigations for Medtronic implantable products (e.g. Implantable Pulse Generators, Implantable Cardioverter Defibrillators, Insertable Loop Recorders, Leads, Delivery systems, etc).
*This includes review or analysis of test results, clinical data, manufacturing data, and product performance data.
POSITION RESPONSIBILITIES:
. Expected to gain a strong understanding of CRDM products and their clinical application, with in-depth knowledge of one product category, including a deep understanding of failure modes and clinical implications
. Perform compliant investigations and assess for product performance issues. This includes assessing complaints with respect to returned product analysis results, clinical data, and manufacturing data.
. Initiate the root cause investigation and corrective action processes.
.Draft reports and other technical documents.
.Ensure the correct application of the quality system.
.Assist Technical Services and Physician Communications departments in assuring accurate and meaningful information is communicated to the customer.
.Assist MDR and Regulatory Affairs as necessary to aid in the response to inquiries or to prepare for regulatory reports.
BASIC QUALIFICATIONS:
.Proficiency with standard desktop PC tools suites.
.Experience with data query and statistical analysis using software tools such as; Minitab, Microsoft Excel, Business Objects, and Spotfire.
.Proficient in developing charts, graphs, and data summaries.
.Regulated industry engineering experience.
EDUCATION REQUIRED:
*BS or higher in Engineering, Physics, Materials Science, Chemistry, or related technical field.
Oral Communication: Excellent
Written Communication: Excellent
YEARS OF EXPERIENCE:
*2-4 Years with Bachelors, 0-2 Years with Masters.
.Knowledge of cardiac rhythm products and therapies.
.Knowledge and application of complaint investigation and methodologies to systematically identify root causes of quality problems. |
