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Lead Systems Architect
2 months ago
Job Overview
The Principal Systems Engineer is responsible for transforming user requirements into comprehensive system specifications, establishing system architecture, and conducting thorough systems analysis, including design trade-offs, performance metrics, and risk assessment. Collaborating with a team of engineers from various disciplines, the Principal Systems Engineer will design, test, and refine instruments and modules, ensuring they meet specified requirements prior to production.
This role is pivotal in ensuring compliance with regulatory standards and addressing any product or technical risks that may emerge throughout the project lifecycle. The Principal Systems Engineer will maintain close collaboration with product stakeholders to guarantee that the final product aligns with customer expectations.
Key Responsibilities
Spearhead the development of system-level concepts and analyses for new project initiatives. Evaluate and provide feedback on concepts generated by the proposal team. Prepare detailed Systems Engineering cost and timeline estimates for significant design development projects. Offer technical presentation support and guidance to the Business Development Team during proposal phases and throughout the development process. Organize and oversee engineering tests to assess the operational characteristics of products or processes. Convert test results into actionable design requirements and criteria. Collaborate with various engineering disciplines to ensure that instrument or module designs fulfill system/module specifications. Conduct Technical Design Reviews at different stages of development to ensure that both conceptual and detailed approaches, along with supporting analyses, lead to compliant designs. Contribute to System Integration efforts and lead Design Verification processes by defining, specifying, and supervising testing, analysis, and integration activities. Ensure comprehensive reports are generated to document the outcomes of these activities. Support the design review and phase gate processes to ensure that engineering outputs meet FDA/ISO standards and requirements. Responsible for overseeing the development of requirements across various disciplines, including Software, Electrical, Mechanical, and Electro-optics.Required Qualifications
Bachelor's Degree in Engineering. A minimum of 9 years of experience in complex electro-mechanical instrument systems engineering. Experience in hardware/software integration. Must be available for regular onsite engagement.Preferred Qualifications:
Master's Degree in Engineering. Experience in the medical device sector. Extensive development experience in one or more of the following engineering fields: software, mechanical, electrical, optics, fluidics, with a solid understanding of advanced theories, concepts, principles, and processes. Proven ability to provide technical leadership during the exploration of complex medical instrumentation products, overseeing the development of requirements across multiple disciplines such as Software, Electrical, Mechanical, and Electro-optics.