Engineer, Medical Device, Equipment and Method validation – Hybrid (JP15044)

3 Key Consulting • Thousand Oaks, CA

5d • Hybrid

About The Position

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations. Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for container closure integrity testing (CCIT) related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution. Assist with project definition by performing engineering studies and assessment for CCIT system installations. Perform field evaluations of existing systems and provide engineering design recommendations and support development of CCIT technologies.

Requirements

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership.

Nice To Haves

• Previous intern experience is a plus
• Experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics.
• Statistical analysis, and knowledge of Gage R&R
• Knowledge of Optical measurement devices, force testers, BLE testing.
• Test method development, CAD design, SolidWorks, mechanical modeling.
• Manufacturing experience, IQ, OQ, and PQ.

Responsibilities

• Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies.
• Troubleshooting of various lab instruments and automation systems, which will require learning the specific software controlling the instruments and integrated systems from vendor manuals, and site documents.

What This Job Offers

• Career Level: Entry Level