EU MDR Remediation Engineer (Contract)
Grand Rapids, MI
DISHER – Manufacturing Technology Solutions /
DISHER DEN/Contract /
Hybrid
EU MDR Remediation Engineer (Contract) – Grand Rapids, Michigan
DISHER is seeking an EU MDR Remediation Engineer for our medical device manufacturing customer in Grand Rapids, Michigan. This CONTRACT role will allow you to play a crucial role in ensuring that their medical devices comply with the stringent requirements of the EU MDR.
What it’s like to work here:
Our customer is the leading consumable breathing products company in the world with a focus on respiratory, anesthesia, and patient monitoring products. They are committed to providing best-in-class service, quality, and customer satisfaction. They appreciate people of different backgrounds and points of view. This company explores new possibilities and are willing to approach issues differently. They have uncomplicated and uncompromising understanding of right from wrong, both publicly and privately.
What you will get to do:
- Complete gap assessment of missing documentation for full EU MDR compliance of product families
- Work with a cross functional team to put together a plan for gap closure
- Write protocols and reports for design verification
- Own the products traceability matrix
- Work with the bio team to identify worst case samples for testing
- Complete all engineering activities related to MDR compliance, while supporting cross functional team members gap closures
What will make you successful:
- Familiarity with EU MDR
- Bachelor's degree in Mechanical/Product Design engineering
- Familiarity with risk management and its relationship to design controls
- Understanding of Basic Statistics
$50 - $65 an hour
About DISHER:
DISHER is a nationally recognized engineering, manufacturing technology, and technical recruiting firm based in Zeeland, Michigan. Our diverse team of top talent comes alongside clients within multiple industries to solve their unique challenges. DISHER truly is a great place to work. Our mission? To Make a Positive Difference with our customers, coworkers, and communities. Every day we strive to leave this world better than we found it. It is what motivates our caring team and unifies our culture.
