R&D Test Engineer [Entry Level]

Position Overview

Position: R&D Test Engineer
Location: Franklin Lakes, NJ
Schedule: 1st Shift, 40 Hours/week

Duration:

Employment Type:

Client:

Key Responsibilities:

• Support engineering studies and Design Verification activities for Intelliport products.
• Perform comprehensive hardware testing on disposable sensors and reusable electro-mechanical devices.
• Contribute to the improvement of testing methods, measurement system development, fixture optimization, and test method analysis.
• Ensure that all products meet customer expectations and regulatory requirements, including adherence to design controls and quality standards such as 21 CFR 820.30.

Required Qualifications:

• Education: Bachelor’s degree in Mechanical Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, Applied Physics or a related field.
• Proficient in reading and understanding assembly drawings, manufacturing and test instructions, and service manuals.
• Excellent written and verbal communication skills.
• Self-directed with the ability to learn and adapt quickly to new technologies and trends.
• Strong organization and coordination skills with the ability to work independently after receiving appropriate direction.
• Detail-oriented and disciplined in performing laboratory tests and accurately recording results.
• Ability to read and follow Standard Operating Procedures, Good Laboratory Practices, and Good Documentation Practices.

Preferred Qualifications:

• Experience in testing medical device products for Design Verification.
• Knowledge of testing software, firmware, and hardware by following established test protocols.
• Familiarity with regulatory standards applicable to medical device design, including FDA QSR, ISO 13845, ISO 14971, IEC 60601, and collateral standards.
• Post-educational experience in Medical Device Design.
• Training or experience in Design for Six Sigma, Design for Manufacturability, and Reliability.
• Graduate degree in a related engineering field such as Mechanical, Systems, Biomedical, Electrical Engineering, or Applied Physics.
• Fluency in CAD modeling software such as Solidworks or ProE.