Job Description
We are seeking an experienced Systems Engineer to lead and manage complex engineering projects. The ideal candidate will have a strong background in systems engineering lifecycle, requirements analysis, system architecture design, and stakeholder management. Prior experience in regulated industries such as medical devices is preferred.
Key Responsibilities:Serve as a technical expert and lead, providing guidance on system evaluation, application, and decision-making.
Lead systems engineering processes including market research, requirements generation, decomposition, traceability, and design analysis.
Develop and implement system architectures and high-level designs, ensuring alignment with project objectives.
Conduct technical presentations for stakeholders at various management levels.
Collaborate with third-party vendors for system components, applications, and integrations.
Oversee test planning, verification & validation, and certification processes.
Manage Safety Risk Management and ensure compliance with industry and government regulations.
Lead root cause investigations and corrective action initiatives under the Corrective Action/Preventive Action (CAPA) process.
Work in compliance with relevant standards such as ISO , IEC -, IEC , and IEC -- (preferred but not required).
Effectively manage stakeholders and collaborate with cross-functional teams to drive project success.
Bachelor's or Master's degree in Systems Engineering, Electrical Engineering, Computer Science, or a related field.
Proven experience in systems engineering, particularly in regulated environments (, medical devices preferred).
Strong understanding of systems architecture, requirements analysis, and verification & validation.
Experience with government regulations and ISO standards.
Excellent problem-solving and decision-making skills.
Strong communication and stakeholder management abilities.
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