OverviewSystems Engineering is an engineering discipline focused on creating and executing an interdisciplinary process to ensure that the customer and stakeholder's needs are satisfied in a high quality, trustworthy, cost-efficient and schedule-compliant manner throughout a system's entire life cycle.The Senior Systems Engineer will lead system definition / development activities in one or more medical device development projects, and act as a contributor to other projects.ResponsibilitiesUnderstands the intent, constraints and value proposition of a given project. Aligns system engineering activities to meet these.Acquires expertise in existing device performance and behaviour to guide lifecycle management projects.Conceptualizes complete solutions. Creates or coordinates the design solutions for novel or complex problemsCreates and assesses system architecture options with cross-functional (electrical / mechanical / SW) team to define optimal system solution.Works with program core team members including Software, Electrical and Mechanical engineering along with Quality and Regulatory to ensure conformance to established design development processes and proceduresTranslates User Needs (from multiple internal and external stakeholders) into verifiable technical design requirements.Decompose system requirements to subsystem requirements (including SW), ensuring functional coverage.Executes work under companies design controls process and in compliance with the company’s quality management system.Works with multiple internal stakeholder groups (Verification, Validation, Quality, Commercial, Clinical, Regulatory Affairs etc.) to resolve system definition challenges.Assesses and clearly communicates technical status of projects.QualificationsBS or MS degree in a scientific or engineering discipline5+ years Systems Engineering experience in complex electro-mechanical productsApplied knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, IEC 60601, IEC 62304 etc.).Familiarity with requirements management tools (e.g., DOORS, Polarion, Jama), as well as modelling-based systems engineering tools (e.g., Enterprise Architect, IBM Rhapsody) preferable.Seniority levelMid-Senior levelEmployment typeFull-timeIndustriesMedical Equipment Manufacturing and Pharmaceutical Manufacturing
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