Principal Systems Engineer

POSITION SUMMARY:

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.

ESSENTIAL FUNCTIONS OF THE POSITION:

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

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

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

BASIC QUALIFICATIONS:

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%

PREFERRED QUALIFICATIONS:

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

OTHER REQUIREMENTS:

Ability to regularly walk, sit, or stand as needed

Ability to occasionally bend and push/pull as needed

Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds

Ability to pass pre-employment drug screen and background check

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Positions in Minnesota

Minnesota pay range

$111,000—$163,000 USD