Principal System Engineer with Medical Devise Industry

Role :

Principal System Engineer Location :

Minnetonka, MN Duration:

Long-Term Contract Job Description 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 Client 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 client 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.