Pharma, Medical Technology & Life Sciences
Freelance · ExpertRemote
Senior Risk Management Engineer – Medical Device Software (m/f/d)
Key facts
- Start
- 11/2026
- Duration
- 2 months+
- Work mode
- Remote
- Location
- Germany (remote)
- Workload
- 100 %
- Contract type
- Freelance · Expert
Project description
A leading medical technology company in the implant sector is continuing to develop its surgical planning software. The company is seeking a Senior Risk Management Engineer to oversee risk management for medical device software (SaMD).
Responsibilities
- Responsibility for software risk management throughout the entire life cycle in accordance with ISO 14971 and IEC 62304
- Conducting hazard analyses, risk assessments, benefit-risk analyses, and residual risk assessments
- Reviewing and verifying risk control measures
- Integrating risk management into requirements, architecture, verification, validation, and post-market activities
- Assessment of software-specific risks, particularly algorithmic, Cybersecurity, usability, and AI/ML-related risks
- Document-driven collaboration with subject matter experts in the risk management process
- Result: an updated, regulatory-compliant Risk Management File
Requirements
Must-have
These criteria are required for the project.
- Several years of practical experience in risk management for medical device software (SaMD)
- Proficiency in ISO 14971 and IEC 62304
- Experience with design controls and regulatory documentation
- Experience in managing complex software-related risks (algorithmic, Cybersecurity, usability, AI/ML)
- Business-fluent English (C2) as the language for team communication and documentation
Nice-to-have
Not required, but a plus for your application.
- Experience with AI/ML-based medical devices
- Domain expertise in medical imaging or clinical workflow software
- Experience with cardiovascular applications
- Experience with risk analyses for implant-related medical devices
Skills
- ISO 14971
- IEC 62304
- Risikomanagement
- SaMD
- Risk Management File
- Cybersecurity
- KI/ML-Risiken
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