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About the role
Key responsibilities & impact- Drive and support design control and product risk management activities in development projects.
- Translate stakeholders into clear, high-quality system and subsystem requirements with end-to-end traceability.
- Own and contribute to systems engineering documentation, including design input/output, product description, and risk documentation.
- Support design verification and validation planning and execution in close collaboration with Test Engineering.
- Participate in design reviews, change control, and impact assessments.
- Ensure compliance with applicable regulatory and quality requirements (e.g. MDR, FDA, ISO 13485, ISO 14971).
- Collaborate closely with cross-functional project teams to support timely project execution.
Requirements
What you’ll need- Degree in engineering or a similar technical discipline.
- Experience with systems engineering and design control in a regulated environment (medical devices are an advantage).
- Knowledge of risk management, requirements engineering, and traceability.
- Experience working cross-functionally with R&D, Test, Quality, and Regulatory stakeholders.
- Strong analytical and communication skills.
- Experience with Polarion or similar ALM tools is an advantage.
Benefits
Comp & perks- A 12-months temporary position in a collaborative and learning environment with strong focus on quality, high professional standards, good sparring and learning.
- You will get real responsibility from the start and the opportunity to build strong capability in systems engineering and regulated product development.
- You will collaborate closely with experienced colleagues in Systems Engineering, Test Engineering, and Product Development.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
systems engineeringdesign controlrisk managementrequirements engineeringtraceabilitydesign verificationdesign validation
Soft Skills
analytical skillscommunication skillscollaborationproject execution
Certifications
ISO 13485ISO 14971MDRFDA compliance