System Engineer

Job Overview:

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.

Required Qualifications:

• 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.