System Design Engineer

ITech Consult AG; Zug; Vor Ort; CHF 100.000 - 140.000; Vollzeit

Benefits dieser Stelle

Health insurance

Zusammenfassung

ITech Consult AG seeks a Systems Engineer to support product development with a focus on critical risk and safety standards for medical devices and IVD devices. The role requires experience with design controls and risk management to ensure GMP-compliant documentation and quality processes.

The candidate should hold a degree in engineering or physics and have 3+ years in product development with familiarity of ISO 14971 and IEC 62304.

Qualifikationen

• A degree in Electrical/Mechanical/Software engineering, Physics or similar.
• More than 3 years experience in product development.
• Safety standards, including ISO 14971, IEC 60601-1, IEC 61508, and IEC 62304.
• GMP experience, experience with Design controls, good documentation practice, design transfer, risk management and quality process compliance.

Ausbildung

Electrical/Mechanical/Software engineering, Physics or similar

Tools

ISO 14971

IEC 60601-1

IEC 61508

IEC 62304

Jobbeschreibung

Systems Engineer/System Design Engineer/ Risks and Safety Standards: Product Development / Critical Risk /Safety Standards / documentation / Medical Devices / IVD devices /

Must Haves:

• A degree in Electrical/Mechanical/Software engineering, Physics or similar
• More than 3 years experience in product development
• Safety standards, including ISO 14971, IEC 60601-1, IEC 61508, and IEC 62304
• GMP experience, experience with Design controls, good documentation practice, design transfer, risk management and quality process compliance