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Test Engineer Resume

North Haven, CT

SUMMARY

  • Performance driven Six  engineer with 12+ years of experience with medical devices including Clinical
  • New Product Development. A natural leader with a reputation for excellence, a strong work ethic, drive to solve difficult problems, and the discipline to analyze, research, organize, and manage complex projects.
  • Committed to career development within a company that fosters educational and growth opportunities.

TECHNICAL SKILLS

  • Linux
  • C
  • C++
  • MATLAB
  • LabVIEW
  • Troubleshoot
  • FDA 21 CFR
  • ISO 13485
  • GDP
  • GMP
  • JAMA SaaS
  • Application
  • Oracle Agile
  • Microsoft PowerPoint
  • Microsoft Excel
  • Microsoft SharePoint
  • Microsoft OneNote

PROFESSIONAL EXPERIENCE

Confidential, North Haven, CT

Test Engineer

Responsibilities:

  • Develop, validate and execute Test Methods and Protocols to support Reliability assessment and identify acceleration factors associated with life test data modeling of critical hardware components
  • Design and validate test fixtures for reliability testing of critical hardware components
  • Validate equipment and generate IQ, OQ, PQ, CQ documents
  • Perform Root - Cause Analysis, Root-Cause Failure Analysis and Failure Mode Effectiveness Analysis (RCA, RCFA, FMEA) and implement Corrective Active Preventive Action (CAPA) as necessary
  • Author reports for Highly Accelerated Life Testing (HALT) and reliability demonstrations for system hardware testing that include statistical and data analyses acquired from testing results
  • Use CAD modeling design software to build components, assemblies and detailed drawings
  • Coordinate with Systems Test Engineers to execute baseline studies and safety testing
  • Contribute to cross-functional teams for root cause analysis and reliability growth activities
  • Identify and report user experience, system/component/instrument performance and failure observations, and communicate to design engineers and internal stakeholders
  • Investigate and analyze relevant variables potentially affecting product and processes
  • Manage calibration of equipment and instruments in order to follow compliance of ISO 9001

Confidential

Clinical Cardiac Device Technician

Responsibilities:

  • Served as a resource for clinical support in areas of basic troubleshooting and programming of medical devices
  • Performed clinical validation including documentation diagnostics, claims submission, payer reviews, audits and denials, regulatory compliance
  • Attended unit implants in Cath/EP Labs and operating rooms of hospital accounts and performing patient follow-up to assure customer and patient success with implanted products
  • Educated customers on the merits and proper clinical usage of implanted devices
  • Developed a database that actively tracked implanted devices patients by vendor, serial and lead numbers
  • Performed this job in a quality system environment; failure to adequately perform tasks can results in noncompliance with governmental regulations

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