Principal System Engineer
Principal Systems EngineerLocation: Minnetonka, MinnesotaMust-Have SkillsSystems EngineeringMedical Device Product DevelopmentCapital Equipment Design & DevelopmentElectrical Engineering and Circuit DesignHardware/Software IntegrationVerification & Validation (V&V)Design ControlsFDA QSR 21 CFR Part 820ISO 13485Requirements ManagementRisk Analysis and TroubleshootingProtocol and Report WritingHuman Factors and Usability EngineeringVoice of Customer (VOC) TranslationCross-Functional Team LeadershipSupplier ManagementIntellectual Property DevelopmentWe are seeking a Principal Systems Engineer with 15+ years of experience to lead the design, development, integration, and testing of complex medical capital equipment used in cardiac surgery and electrophysiology. This role requires strong expertise in systems engineering, electrical and circuit design, hardware/software integration, verification and validation, and medical device design controls. The ideal candidate will have deep knowledge of FDA 21 CFR Part 820, ISO 13485, human factors, and usability engineering, along with proven experience translating clinician and customer needs into technical requirements. This individual will collaborate with cross-functional teams, manage external suppliers, mentor junior engineers, and drive innovative product development from concept through commercialization.Required QualificationsBachelor’s degree in Engineering (Systems, Electrical, Mechanical, or related field).15+ years of systems engineering or related experience.Strong experience with hardware/software development methodologies and structured system development.Solid understanding of electrical circuits and circuit design.Experience with medical device design controls and manufacturing processes.Working knowledge of FDA QSR 21 CFR Part 820 and ISO 13485.Experience translating customer requirements into technical specifications.Strong skills in data analysis, troubleshooting, and root cause analysis.Ability to read and interpret technical drawings, specifications, and blueprints.Experience with protocol and report writing.Knowledge of usability engineering and international usability standards.Ability to travel up to 25%.