Test Engineer

Location: North Haven, Connecticut
Posted On: 9/7/2017
Job Code: 7460_TestE_CT_NH
Job Description

ABSOULTELY MUST HAVE: 10 – 20 years’ experience in complex medical device development with a thorough understanding of the FDA regulatory environment and the rigor required for formal medical device system verification.

• Rapidly read, interpret, and understand large complex electro-mechanical medical system requirements.
• Write detailed protocols for formal verification of complex electro-mechanical medical system requirements.
• Expertly assess, interpret, characterize, judge, and summarize formal verification test results.
• Extensive experience in formulating, compiling, writing, and delivering rigorous comprehensive engineering verification test reports.
• Excellent English language technical writing skills.

• Work in a multi-disciplinary team developing test methods for a complex, electro-mechanical system
• Support, review and provide constructive feedback on test methods developed by peers
• Plan, execute, and document test method validation studies
• Assist in the design and/or procurement of needed test equipment or fixtures
• Develop test software using standard lab software such as LabVIEW.
• Execute System testing, and write detailed verification test reports
• Communicate status of test development and execution to management
• Participate in reviews of negative test outcomes, and provide root cause analysis input and/or suggestions on test method optimization

• Knowledge of principles and applications of biomechanics, and electrical, mechanical & software development.
• Understanding of basic System Engineering or requirements-driven product development principles
• Communicate effectively with cross-functional and multi-site teams.
• Has experience using a variety of office and engineering software, including MS Office, Pro-E, Solidworks, AutoCAD, MATLAB or LabVIEW, etc.
• Knowledge of statistical software packages (Minitab) and applications.
• Understanding of ISO 13485, ISO 60601, ISO 14971

Other Beneficial Skills/Qualifications:
• Understanding of medical device industry, clinical anatomy, and competitor products. Knowledge of other related disciplines including cross functional fields and market competition.
• Awareness of clinical and regulatory pathways, IP and internal processes.

Minimum of B.S. (or equivalent) degree in Engineering, Math, Computer Science or related field.
10 – 20 years’ direct medical device verification experience in complex medical device developments. A thorough understanding of the FDA regulatory environment and the rigor required for formal medical device system verification.
Category:IT  code:new
Job Requirements
J2ME, AutoCAD, MS Office, LabVIEW, Direct3D, Management, Engineering, COM, STE, Software Development, SolidWorks, ISO 9001, Matlab, Java, Procurement

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Contact Details
Sparsh Patel
E-mail Address