Test Engineer Resume North Haven, CT - Hire IT People

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

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