Systems Engineer

The Systems Engineer is an Exempt/Full-Time position that works alongside the development team to ensure product specifications are achieved and in compliance with medical regulatory practices and company procedures.

Requirements

• 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.
• 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.
• Incorporates business, market, industry, and competitive knowledge into technical solutions.
• Determines required tasks and completes on time with minimal supervision.
• Identifies and communicates potential risks with appropriate mitigations.
• Synthesizes complex information gathered from a variety of sources and disseminates to others.

Benefits

• Paid time off
• 401(k) matching
• Health insurance
• Dental insurance
• Vision insurance