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Prominent Medical Devices Company

JOB TITLE: Test Engineer II
CLIENT:  A prominent Medical Devices Company
CONTRACT: 9 months initial contract (04/17/2017 to 01/17/2018)
LOCATION: North Haven Connecticut USA 
Pay Rate: Open
1st Shift
Must Haves:
Team Player
Good engineering/science background
Software skills
POSITION SUMMARY:
A new product development team for the Surgical Innovation business in company's Minimally Invasive Therapies Group (MITG) Business Unit is seeking a System Test Engineer. The System Test Engineer will be responsible for supporting the development of a minimally invasive platform for the R&D organization by developing, reviewing, validating, and executing System verification testing for a complex, robotic surgical system. The candidate will be responsible for ensuring that verification methods developed are testable, repeatable, reproducible, and are adequate for verifying applicable System Requirements, while adhering to internal Quality System processes and applicable regulations. The candidate should have a good understanding of System Engineering, Design Control for medical devices, and product requirements verification and related processes. The candidate shall have excellent written and oral communication skills and should be able to work in a multi-site team environment. This position will be a part of a R&D Systems Engineering team; and will interface with cross-functional team members.
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 system
Support, review and provide constructive feedback on test methods developed by peers
Plan, execute, and document test method validation studies
Assist in the procurement of needed test equipment/fixtures
Execute System testing, and write test reports when support is needed
Communicate status of test methods in development
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, mechatronics, and electrical, mechanical or software development.
Experienced using and programming a variety of engineering software, including MATLAB and LabView
Understanding of basic System Engineering or requirements-driven product development principles
Communicates effectively with cross-functional and multi-site teams.
Knowledge of statistical software packages (e.g. 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:
Minimum 5 years of experience in medical device development, preferably with electro-mechanical, robotic, or software applications/products. 3+ years of direct involvement with medical device verification.

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