Product Development V & V Engineer

DYNEX Technologies manufactures and markets in vitro diagnostic and research instrumentation, systems, software and disposables on a global basis.  Our products incorporate advanced detection and fully-automated sample handling and are used in clinical diagnostics, drug discovery, and biomedical research.

 

An experienced Systems Engineer is needed to work within a medical product development department and take responsibility for the verification and validation of both software and hardware projects.  You will work with an established development team that carries out Software, Firmware, Electronic and Mechanical design to produce automated systems for in-house manufacture.

 

Responsibilities:

 

Create verification test plans and test scripts from product specifications; carry out internal testing, instruct technicians to run tests following test scripts and produce test reports for system hardware including MTBF testing, system software and firmware development.

 

Coordinate external testing required for regulatory approval.  Liaise with test contractors for all aspects of product testing to meet CE standards.

 

Coordinate Beta testing, produce Beta questionnaires, validation scripts and reports to qualify product suitability to customers.

 

Lead a team of verification & validation engineers and technicians

 

Qualifications:

 BS degree in EE or CS5+ years of quality assurance experience specifically in software, hardware and system verification and validation planning and executionExperience working in an FDA and ISO regulated environmentExperience working with statistical methods and risk analysis processes such as MTBF calculations, and Fault Tree AnalysisExperience with automated test equipment and tools Experience with robotic based systems Must be able to work independently and have a demonstrated track record for coordinating the work of others (such as external contractors)Supervisory experience leading a V & V team

 

DYNEX is an Equal Opportunity Employer and provides medical, dental, life and disability insurance, Section 125, 401(k), flexible schedules, educational assistance and a great work environment!

 

Please forward resume as a Word attachemnt including salary requirements.

 

Visit our website www.dynextechnologies.com

 

Dynex Technologies is a Magellan Biosciences Company www.magellanbio.com