System EngineerThe System Engineer will provide technical leadership and oversight for the development of new medical devices developed in conjunction with our client's customer partners in a fast-paced environment. The System Engineer will develop systems engineering deliverables such as requirements, product architecture, and risk analysis and be a key team member working closely with the customer's team. The ideal candidate will have a successful track record of leading technical product development teams and launching products into production.Job ResponsibilitiesRequirements management and developmentSystem architecture definition including interface definition and interaction diagramsRisk Management including DFMEAConcept Development including evaluation and selectionTechnology / key component selectionOversee HW/SW integrationWork with product verification team for test method developmentParticipate in prototype build activitiesRoot cause investigation of technical issuesBe customer facing and interface with the customer's technical teamRequired ExpertiseSolid critical thinking and decision-making skillsAbility to work closely with the project manager and drive action within the teamClearly communicate complex information especially with the management teamKnowledge of the medical device standards and regulations such as IEC 60601 or ISO 11608Desired SkillsEco-design techniques a plusExperience with using Modern Requirements or similar requirements management toolsExperience with using APIS or similar DFMEA toolsExperience with MatLab / SimulinkManufacturing process developmentEducation and Work History RequirementsBS in ME, EE, SW, or Biomedical engineering is requiredAt least 10+ years of relevant experience in medical device developmentExperience managing entire design cycles from concept to production