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.

```{=html}

``` - 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.