Systems Engineer (Hybrid)

Remote / Hybrid

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 60601-1 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.

Requirements

A Bachelor’s degree is required.

3+ years of Systems Engineering experience.

Industry experience must be from a regulated environment such as Medical Device, Aerospace, Military, Space or Automotive.

Product development experience is highly desirable.

Involvement with regulatory standards such as IEC 60601, IEC 62304, ISO 14971 and/or ISO 13485.

Experience with system risk/hazard analysis.

Experience with FDA 510(k) product/testing requirements is a plus.

Experience working in Quality or Regulatory capacities in the medical device industry is ideal.

Skilled in developing test plans and validation protocols in a regulated environment.

Capability of using automated software testing tools.

Familiarity with numerical analysis and methods.

Demonstrable experience in performing risk assessment, software validation and testing.