Role OverviewThe Sr. R&D Engineer role provides engineering support for design control activities while overseeing cross-functional efforts across design, quality, manufacturing, and project execution.
What You Will Do
Provides engineering support for design control activities, oversees design, quality, manufacturing, and project related activities, and coordinates with internal functions and external suppliers to identify and execute projects.
Why It Might Be a Fit
The ideal candidate will have 5+ years of experience working with design controls, experience with FDA Quality System Regulations and ISO 13485, and experience with design verification and validations activities.
Requirements
- 5+ years working with design controls
- 5+ years working within FDA Quality System Regulations and ISO 13485
- Experience with assessing quality and compliance impact on products for design and process changes
- Experience with design verification and validations activities
- Experience with Test Method development
- Experience in troubleshooting and root cause analysis
- Self-motivated individual that can work independently
- Working knowledge of MiniTab and SolidWorks
- Good writing (assessments, protocols, reports, and email) and verbal communication skills
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