Test Engineer II

PSG Global Solutions; North Haven (CT); On-site; USD 80,000 - 110,000; Full time

Job summary

A prominent Medical Devices Company is seeking a System Test Engineer II for their new product development team in North Haven. This role includes developing and executing system verification testing for a robotic surgical system, requiring a strong engineering/science background and proficiency in tools like MATLAB and LabView. The ideal candidate has a minimum of 5 years' experience in medical device development and excellent communication skills to work in a multi-site team environment.

Qualifications

• Minimum of 5 years of experience in medical device development, preferably with electro-mechanical or robotic systems.
• 3+ years of direct involvement with medical device verification.
• Understanding of ISO 13485, ISO 60601, ISO 14971.

Responsibilities

• Work in a multi-disciplinary team developing test methods for a complex, electro-mechanical system.
• Support, review and provide feedback on test methods developed by peers.
• Plan, execute, and document test method validation studies.

Skills

Team Player

Good engineering/science background

Software skills

Education

B.S. in Engineering, Math, Computer Science or related field

Tools

MATLAB

LabView

Minitab

Job description

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

Shift: 1st Shift

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

• 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.