System Test Engineer

 
Location: North Haven, Connecticut
Posted On: 9/13/2017
Job Code: 7460_TestE_CT_NH
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Job Description
 
Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The System Test Engineer is responsible for:
• Work in a multi-disciplinary team developing test methods for a complex, electro-mechanical surgical system
• Support, review and provide constructive feedback on test methods developed by peers
• Plan, execute, and document test method validation studies
• Develop detailed design verification protocols and reports including engineering rationales for test approach and sample size for verification of capital/serviceable equipment
• Communicate status of test development and protocol 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:
• Understanding of basic requirements of medical device design verification per appropriate standards, regulations, and regulatory body expectations
• Understanding of basic System Engineering or requirements-driven product development and verification principles
• Direct experience developing/authoring design verification protocols and reports
• Communicates effectively with cross-functional and multi-site teams.
• 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.
• Experience with verification or validation of capital medical equipment (vs high-volume equipment) STRONGLY preferred

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

EXPERIENCE:
Minimum of 3 years of direct experience in medical device development and verification, preferably with low-volume or serviceable/capital medical equipment.
Category:Non-IT  code:new
 
 
Job Requirements
 
 
Validation,verification,test,medical device,Minitab,ISO 13485, ISO 60601, ISO 14971
 

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Contact Details
 
Recruiter
Sparsh Patel
 
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