Position: R&D Test Engineer [Entry Level]

Location: Franklin Lakes, NJ

Duration: 12+ Months Contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Description:

For the hardware tester position, it has to be local FLKS site. For testing, needs to be in lab every week day.

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.

The R&D test engineer will support engineering studies and Design Verification activities for the Intelliport products including disposable sensors and several reusable electro-mechanical devices. In addition to testing, this associate may also contribute to the improvement of testing methods, measurement system development & analysis of test methods, the improvement of fixtures, data processing and analysis. The testing performed in this role will help ensure that our products meet our customer’s expectations and regulatory requirements. Knowledge of disciplined product development processes, regulatory, quality requirements and design controls, such as 21 CFR 820.30 is a plus.

Minimum Qualifications:
• 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.

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