Senior Design Assurance Engineer - 12 month FTC
Core
Partner with internal and external colleagues to plan and execute Post Market Strategies for continuous improvement of products, methodologies, processes, and departmental interfaces within the Coronary/RDN Post Market Design Assurance Department.
Role type
Senior Design Assurance Engineer (Post Market)
Builds
Continuous improvement strategies for medical technologies
Domain
Healthcare technology / Medical devices (Coronary/RDN)
Deliverable
client delivery
Required skills
Design Assurance support, ISO13485/14971/21 CFR regulatory standards knowledge, risk management guidance, audit representation (MDR/MDSAP/FDA), cross-functional collaboration, change management, technical writing
Preferred skills
Complaint trending, Post Market Surveillance
Technologies
ISO13485, ISO14971, 21 CFR
Responsibilities
Provide Design Assurance support to OU Sustaining & product Surveillance initiatives, Engage with risk management teams to provide focused technical guidance, Represent the department in supporting internal and external audits, Contribute to establishing best practice in accordance with regulatory requirements, Drive Engagement & mindfulness initiatives, Contribute to continuous improvement strategies
Seniority
Senior, hands-on IC