đź“Ť Switzerland | Hybrid
ISO 14971 | Risk-Based Development | Medical Devices | MDR | Product Development
For an internationally active MedTech company in Switzerland, we are looking for an experienced professional to lead and further develop product risk management within the product development organization.
This role combines strategic responsibility with hands‑on expertise in risk-based development of medical devices and offers the opportunity to shape and strengthen risk management processes across development projects.
Responsibilities
* Lead and further develop the product risk management function
* Ensure implementation of ISO 14971-compliant risk management processes
* Act as the central expert for product risk management across development projects
* Support cross-functional development teams in risk-based product development
* Facilitate risk analyses such as FMEA, hazard analysis and risk evaluations
* Ensure robust risk documentation and audit readiness
* Drive continuous improvement of risk management processes and tools
* Contribute to post-market risk management, including evaluation of field data and benefit-risk assessments
Requirements
* Degree in engineering, biomedical engineering or life sciences
* Strong experience in risk management for medical devices
* Deep knowledge of ISO 14971, EU MDR and FDA expectations
* Structured, pragmatic and solution-oriented working style
* Leadership experience or strong potential to lead a team
* Excellent communication skills and ability to moderate technical discussions
Compensation
* Base salary range: CHF 140'000 – CHF 160'000 depending on experience
* Additional performance-related bonus
* Hybrid working model (up to 2 days home office)
Example Background
Candidates may currently work as:
* Risk Manager – Medical Devices
* Design Assurance Engineer
* Senior Quality Engineer – Risk Management
* Systems Safety / Product Safety Engineer
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