Posted in: Other in Cleveland | Posted: |
Job Description
Responsibilities
Responsible for overall system engineering / testing for a complex electromagnetic surgical navigation product platform.
Develops/maintains system architecture and interface requirements for the products, based on technology and platform strategies.
Defines subassembly interfaces and subassembly requirements to both internal and outsourced design teams.
Implements and tests the product platform to ensure high quality, robust behavior and safety in accordance with medical device regulatory standards and customer requirements.
Responsible for daily system engineering activities including leading issue resolution and communication across teams in order to deliver results on-time and on-budget.
Develops/maintains the risk management file in accordance with ISO 14971 and ensures product safety in accordance with IEC (phone number removed) and its appropriate subparts.
Works with other team members and functions to execute design reviews of complex Medical Devices.
Drives structural design documentation and plans by applying engineering best practices.
Conducts impact analysis for design changes and implements necessary actions including estimates of impact to time, budget, and scope.
Effectively coordinates test activities throughout the project to drive efficiency in V&V in collaboration with the regulatory resource to ensure a complete and effective 510(k) submission.
Understands and follows quality and product development processes.