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:
1. Serve as a technical expert and lead, providing guidance on system evaluation, application, and decision-making.
2. Lead systems engineering processes including market research, requirements generation, decomposition, traceability, and design analysis.
3. Develop and implement system architectures and high-level designs, ensuring alignment with project objectives.
4. Conduct technical presentations for stakeholders at various management levels.
5. Collaborate with third-party vendors for system components, applications, and integrations.
6. Oversee test planning, verification & validation, and certification processes.
7. Manage Safety Risk Management and ensure compliance with industry and government regulations.
8. Lead root cause investigations and corrective action initiatives under the Corrective Action/Preventive Action (CAPA) process.
9. Work in compliance with relevant standards such as ISO, IEC -, IEC, and IEC -- (preferred but not required).
10. Effectively manage stakeholders and collaborate with cross-functional teams to drive project success.
Required Qualifications:
11. Bachelor's or Master's degree in Systems Engineering, Electrical Engineering, Computer Science, or a related field.
12. Proven experience in systems engineering, particularly in regulated environments (, medical devices preferred).
13. Strong understanding of systems architecture, requirements analysis, and verification & validation.
14. Experience with government regulations and ISO standards.
15. Excellent problem-solving and decision-making skills.
16. Strong communication and stakeholder management abilities.