Staff Design Assurance Engineer at Rhevera Medical · Minneapolis, MN+1 more · Joined
RM
Staff Design Assurance Engineer
Rhevera Medical · Minneapolis, MN+1 more · Just now · 0 applicants
NewOn-siteFull-timeLead
Pay
$110k–$128kListed
Workplace
On-site
Job type
Full-time
Level
Lead
Team: Design Assurance · Source: jobright · Posted by joined-scrapper
About the role
The Staff Design Assurance Engineer will execute design assurance activities for medical device development, primarily supporting the Pounce product line and new product development through design controls, verification and validation, risk management, and regulatory compliance.
What you’ll do
Execute design assurance activities for product development programs
Support the Pounce product line and new product development
Apply design controls, verification and validation, and risk management
Provide cross-functional quality support
Ensure regulatory compliance for medical devices
What you’ll need
Bachelor's degree in Engineering, Life Sciences, or related field, or equivalent experience
3 to 5 years of experience in medical device design quality assurance or related engineering role
Working knowledge of design controls, QMSR (21 CFR Part 820), ISO 13485, and ISO 14971
Experience writing and executing verification and validation protocols and reports
Ability to evaluate technical data and support risk-based decisions; strong collaboration and communication skills
Self-directed and motivated; preferred experience with catheter-based/vascular devices and exposure to Class III devices/PMA pathways
Original job description
Endologix LLC, which operates as a Rhevera Medical company, is hiring a Staff Design Assurance Engineer to execute design assurance activities for product development programs, primarily supporting the Pounce product line and new product development. The role focuses on design controls, verification and validation, risk management, cross-functional quality…