Engineer, Medical Device, Equipment and Method validation – Hybrid (JP15044)
About The Position
This position involves supporting senior staff in the initiation, design, and delivery of projects, particularly for automation and container closure integrity testing (CCIT) related scope. The role requires employing basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third-party firms. The engineer will assist with project definition by performing engineering studies and assessments for automation and CCIT system installations, perform field evaluations of existing systems, and provide engineering design recommendations. Additionally, the role supports the 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
- Hands-on engineering experience.
- Experience in validation and qualifying equipment.
- Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership.
Nice To Haves
- Previous intern experience.
- Experience with automation.
- Experience with computer programming, systems, and/or robotics.
- Statistical analysis.
- 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
- Support senior staff in project initiation, design, and delivery.
- Gather user requirements and translate them into technical documentation.
- Perform engineering studies and assessments for automation and CCIT system installations.
- Conduct field evaluations of existing systems and provide engineering design recommendations.
- Support the development of CCIT technologies.
- Generate Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, and Gauge Repeatability and Reproducibility studies.
- Troubleshoot various lab instruments and automation systems, requiring learning specific software from vendor manuals and site documents.
Benefits
- W2 with benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Career Level
Entry Level
