Overview
Systems 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.
Responsibilities
* Understands 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 problems
* Creates 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 procedures
* Translates 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.
Qualifications
* BS or MS degree in a scientific or engineering discipline
* 5+ years Systems Engineering experience in complex electro-mechanical products
* Applied 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 level
* Mid-Senior level
Employment type
* Full-time
Industries
* Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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