R&D Test Engineer

About the role

The R&D test engineer position is an entry level position, responsible for hardware testing activities to develop and commercialize complex instrumentation in the medication safety space.

Responsibilities

• Support engineering studies and Design Verification activities for the Intelliport products including disposable sensors and several reusable electro-mechanical devices.
• Contribute to the improvement of testing methods, measurement system development & analysis of test methods, the improvement of fixtures, data processing and analysis.
• Ensure that our products meet customer's expectations and regulatory requirements.

Qualifications

• Minimum Qualifications: Bachelor’s degree in Mechanical Engineering, Systems Engineering, Biomedical Engineering, Applied Physics or similar.
• Desired Qualifications: Experience testing medical device product for Design Verification, Knowledge on testing software, firmware and hardware by following test protocols, Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR, ISO 13845, ISO 14971 and IEC 60601 and collateral standards, Post-educational experience in Medical Device Design, Design for Six Sigma, Design for Manufacturability and Reliability training / experience, Graduate degree in Mechanical Engineering, Systems Engineering, Biomedical Engineering or Applied Physics, Fluent in CAD modeling such as Solidworks or ProE.

Competencies

• Excellent written & verbal communication skills
• Self-directed with the ability to learn and adapt quickly to new technologies and trends
• Strong organization and coordination skills
• Ability to work independently after appropriate direction
• Careful, deliberate, disciplined, meticulous, and well organized in performing laboratory tests and recording results
• Ability to read and follow Standard Operation Procedures, Good laboratories Practices, Good Documentation Practices knowledge