Test Engineer

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• 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.

OTHER DUTIES AND RESPONSIBILITIES (as assigned):
• 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


JOB QUALIFICATIONS:
• 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.

EDUCATION:
Minimum of B.S. (or equivalent) degree in Engineering, Math, Computer Science or related field.
EXPERIENCE:
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
 

Not Ready to Apply?
Contact Details
 
Recruiter
Sparsh Patel
 
Phone
 
E-mail Address
 
LinkedIn