Entegee System Test Engineer- 53368231JA in North Haven, Connecticut
System Test Engineer- 53368231JA
Job Code: 53368231Job Location: North Haven, CTCategory: Electrical EngineeringLast Updated: 10/25/2016Apply Now!
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.
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
• Knowledge of principles and applications of biomechanics, mechatronics, and electrical, mechanical or software development.
• Understanding of basic System Engineering or requirements-driven product development principles
• Communicates 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. Programming experience not required.
• 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.
• 3-5 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.
Equal Opportunity Employer
For more information about this position, please contact the Entegee New Hope, MN office at
763-577-9000 or firstname.lastname@example.org.
Please reference job # 53368231JA