Test Engineer

Location: North Haven, Connecticut
Posted On: 9/12/2017
Job Code: Test Engg - North Ha
Job Description
Position 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

• 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

Minimum of B.S. (or equivalent) degree in Engineering, Math, Computer Science or related field.
Minimum of 3 years of direct experience in medical device development and verification, preferably with low-volume or serviceable/capital medical equipment.
Category:IT  code:new
Job Requirements
.NET, ISO 9001, Management, STE, COM, Direct3D, Engineering

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Contact Details
Chirag Sharma
E-mail Address