Risk Management Lead - Medical Devices (ISO 14971)

Hamilton Medical AG; Ems; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Hamilton Medical AG in Switzerland seeks a Lead Risk Manager to drive risk management across the product lifecycle. You will own ISO 14971 processes, consolidate inputs from R&D, Quality, and Regulatory, and guide risk-based decisions.

Requires a Master’s degree in engineering/science, extensive ISO 14971/MDR experience, and strong leadership with bilingual German/English communication. You will shape risk strategies and enable cross-functional collaboration across the organization.

Qualifikationen

• Master's Degree in Engineering, Computer Science, Natural Sciences or related field.
• Practical experience applying risk management (ISO 14971) throughout the medical device lifecycle.
• Solid understanding of standards and regulations (ISO 14971, ISO 13485, MDR, IEC 62304, IEC 62366-1, ISO 60601-1, ISO 10993-1/18562).
• Leadership experience in developing and empowering teams including direct and indirect reports.
• Several years of experience in the medical device industry with a strong technical foundation.
• Very good German and English skills.

Aufgaben

• Lead and develop the Risk Management team, including staffing, task planning, and professional development.
• Ensure that the team delivers high-quality risk analyses, takes well-founded decisions, and maintains audit-ready documentation.
• Establish working practices that enable transparent reasoning, realistic risk evaluation, and traceable documentation.
• Contribute to improving and digitalizing risk management processes, tools, and data structures.

Kenntnisse

Leadership

Risk management

ISO 14971

Stakeholder management

Regulatory compliance

Cross-functional leadership

German/English proficiency

Ausbildung

Master's Degree in Engineering/Computer Science/Natural Sciences

Jobbeschreibung

Hamilton Medical AG in Switzerland seeks a Lead Risk Manager to drive risk management across the product lifecycle. You will own ISO 14971 processes, consolidate inputs from R&D, Quality, and Regulatory, and guide risk-based decisions.

Requires a Master’s degree in engineering/science, extensive ISO 14971/MDR experience, and strong leadership with bilingual German/English communication. You will shape risk strategies and enable cross-functional collaboration across the organization.