R&D Test Engineer [Entry Level]

About the role

The R&D test engineer position is an entry level role responsible for hardware testing activities to develop and commercialize complex instrumentation in the medication safety space. This includes supporting engineering studies and Design Verification activities for the Intelliport products, which include disposable sensors and reusable electro-mechanical devices.

Responsibilities

• Support engineering studies and Design Verification activities for the Intelliport products
• Contribute to the improvement of testing methods, measurement system development & analysis of test methods
• Improve fixtures, data processing and analysis
• Ensure that products meet customer expectations and regulatory requirements

Requirements

• Bachelor’s degree in Mechanical Engineering, Systems Engineering, Biomedical Engineering, Applied Physics or similar
• Proficient in reading and understanding assembly drawings, manufacturing and test instructions, and service manuals
• Experience testing medical device products 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
• Fluent in CAD modeling such as Solidworks or ProE

Qualifications

• Minimum Qualifications: Bachelor’s degree in Mechanical Engineering, Systems Engineering, Biomedical Engineering, Applied Physics or similar
• Desired Qualifications: Graduate degree in Mechanical Engineering, Systems Engineering, Biomedical Engineering or Applied Physics

Skills

• 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
• Knowledge of disciplined product development processes, regulatory, quality requirements and design controls, such as 21 CFR 820.30

Pay

Not specified

Schedule

1st Shift