Job Description

Position: Systems Engineer

The Systems Engineer will work across all teams on the development of our mapping system. Understanding signal processing, electrical system design, and medical device development are key to succeeding in this position. This role is based full time in our Burlington, MA office.

RESPONSIBILITIES

• Work with various R&D (SW, algorithms, HW) and regulatory teams to translate user needs into product requirements for design verification activities
• With QA and Product Design Teams, create and maintain design trace matrices (DTMs) to manage the process for ensuring that desing outputs meet design inputs in compliance with FDA design controls requirements (reference 21 CFR Part 820.30)
• Generate verification protocols and write verification reports
• Coordinate the development of protocols, reports, schedules, resources, suppliers & support implementation and execution activities to meet company goals
• Implement systems engineering methodologies to support development (e.g., DFMEA, Risk Assessment, Design Reviews)
• Work within a regulated environment to produce key documents and drawings & develop rigorous test protocols as needed per FDA guidance

SKILLS AND EXPERIENCE

• B.S or M.S. in Engineering is required
• 5+ years working in medical device development with 3+ years in systems engineering experience is required
• Understanding of the EP lab, including connectivity and noise sources preferred
• Significant experience with systems incorporating complex algorithms, HW, and SW is preferred
• Excellent verbal and written communication skills are required
• Comfortable working in both a rigorous early-stage environment with fluid requirements, as well as a regulated later-stage process-driven setting is required

 

Posted On: Monday, April 29, 2024
Compensation: 150,000