System Engineer

Dabster; Böblingen; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A technology solutions provider in Böblingen is seeking an experienced Systems Engineer to lead complex engineering projects. The ideal candidate possesses a strong background in systems engineering lifecycle and stakeholder management, with preferred experience in regulated environments like medical devices. Responsibilities include managing system architecture, leading engineering processes, and ensuring regulatory compliance. This full-time position offers the opportunity to work in a collaborative environment.

Qualifikationen

• Proven experience in systems engineering, preferably in regulated environments.
• Strong understanding of systems architecture and verification & validation.
• Experience with government regulations and ISO standards.

Aufgaben

• Serve as a technical expert and lead on system evaluation and decision-making.
• Lead systems engineering processes including requirements generation.
• Develop and implement system architectures aligning with project objectives.
• Conduct technical presentations for stakeholders.
• Oversee test planning, verification, and validation processes.
• Manage compliance with industry regulations.
• Collaborate with third-party vendors for integrations.

Kenntnisse

Systems engineering

Requirements analysis

Stakeholder management

Problem-solving

Decision-making

Communication

Ausbildung

Bachelor's or Master's degree in Systems Engineering, Electrical Engineering, Computer Science

Jobbeschreibung

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.

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 60601, IEC 62304, and IEC 62366 (preferred but not required).

10. Effectively manage stakeholders and collaborate with cross-functional teams to drive project success.

Required Qualifications:

1. Bachelor's or Master's degree in Systems Engineering, Electrical Engineering, Computer Science, or a related field.

2. Proven experience in systems engineering, particularly in regulated environments (medical devices preferred).

3. Strong understanding of systems architecture, requirements analysis, and verification & validation.

4. Experience with government regulations and ISO standards.

5. Excellent problem-solving and decision-making skills.

6. Strong communication and stakeholder management abilities.

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