Principal Systems Engineer

AtriCure•Minnetonka, MN

2d•Onsite

About The Position

This position will contribute to the company success through the design and development of capital equipment and devices. This position will report to the Senior Director, Research and Development in our Ablation Franchise. The individual will work on capital equipment projects to design, build, and test next generation capital equipment that is used by cardiac surgeons and electrophysiologists. This position contributes in a collaborative way with management, project teams, production associates, external vendors and other work groups to achieve the company’s goals of producing market-lead products through positive patient outcomes. The Principal Systems Engineer may work independently on projects with broad scope or be a team member on PD project.

Requirements

BS in Engineering
15+ years of experience in systems engineering or equivalent field
Demonstrated skills in System engineering
Experience in hardware/software development methodologies and structured approaches to system development
Must be proficient acting in and leading integrated process teams, as well as coordinating and communicating customer requirements
Demonstrated understanding of circuits and circuit design
Understanding of program management tools and expectations of medical device design and manufacturing controls
Experience working with customers and translating the “Voice of the Customer” into technical specifications
Demonstrated understanding of protocol/report writing
Experience with data analysis, problem-solving, and troubleshooting
Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485
Ability to read technical specifications, blueprints, and drawings
Capable of prioritizing tasks and provide a timely schedule of completion
Capable of sub-assembly level analysis (not limited to circuit, tolerance or finite element analysis)
Demonstrated proficiencies of communicating best practices
Experience with International Usability Standards and the practical application of Usability Engineering
Ability to travel 25%

Nice To Haves

MS degree in Systems Engineering or Electrical Engineering
Excellent demonstrated skills in System engineering
Vast Experience in hardware/software development methodologies and structured approaches to system development
Demonstrated proficiency in leading integrated process teams, as well as coordinating and communicating customer requirements
Excellent written and oral communication skills
Excellent understanding of industry regulations as it pertains to medical devices
Excellent understanding of external standards, design controls, quality controls, manufacturing methods
Proven track record of generating and documenting intellectual property
Experience with Human Factors for medical devices/equipment
Expertise with International Usability Standards and the practical application of Usability Engineering

Responsibilities

Define and lead system development tasks to include design, integration, and formal testing of capital equipment and devices
Develop and complete actions in system specifications, technical and logistical requirements, and other disciplines
Identify and develop a rapport with key customers – surgeons, nurses, and other clinicians
Develop in-depth understanding of clinical procedures and techniques applicable to AtriCure products
Create and maintain programmatic and technical documentation to ensure efficient planning and execution
Aligns and coordinates resources, priorities, work plans, and activities among outside suppliers and the AtriCure Product Development group
Determines work procedures, prepares work schedules, and expedites workflow
Design, develop and test all aspects of electrical components, equipment and machinery
Communicate with and direct external suppliers of components, subassemblies and finished assemblies.
Generate and document intellectual property
Develop and perform stress and performance tests on a variety of electrical/electronic system hardware including circuit boards, processors and wiring
Perform a variety of complex engineering design and development tasks, to include design, testing and analysis, verification, and validation
Develop and validate test methods
Review and authorize engineering design changes
Develop component and product technical specifications including the integration and consideration of applicable standards and regulations
Mentor junior engineers
Regular and predictable work performance
Ability to work under fast-paced conditions
Ability to make decisions and use good judgement
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned