Engineer II, Advanced Surgery
Core
Support the Sustaining Engineering team in maintaining and improving existing products, processes, and systems, focusing on Change Management activities.
Role type
Senior IC sustaining engineering specialist (change management)
Builds
Medical device products and processes
Domain
Medical devices / Healthcare
Required skills
Change management, project monitoring and tracking, quality process implementation, regulatory compliance (ISO 13485, ISO 14971), cross-functional coordination, document preparation and review, risk management
Preferred skills
Experience with change control tools, knowledge of EU regulations
Technologies
ISO 13485, ISO 14971
Responsibilities
Coordinate and track engineering changes and product updates, serve as Single Point of Ownership (SPOC) for team projects, lead cross-functional meetings to communicate priorities and risks, independently drive change controls, ensure project compliance with QA processes and timelines, review changes to existing processes and products
Seniority
Mid-level, hands-on IC