Senior Risk Management Engineer - Medical Device Software

Project overview

A leading medical technology company in the implant segment is further developing its software for surgical planning. A Senior Risk Management Engineer is sought to be responsible for risk management for Medical Device Software / SaMD.

Key Data:

YOUR CHALLENGE:

YOUR TALENTS:

• Start: 01.11.2026
• Duration: 2 months (until 31.12.2026), extension option until summer 2027
• Remote/On-site: Remote (Germany), 1-2 trips to the customer site
• Utilization: 100%
• Location: Germany (remote)
• Responsibility for software risk management throughout the entire lifecycle according to ISO 14971 and IEC 62304
• Conducting hazard analyses, risk assessments, benefit-risk analyses, and evaluation of residual risks
• Review and verification of risk control measures
• Integration of risk management into requirements, architecture, verification, validation, and post-market activities
• Assessment of software-specific risks, especially algorithmic, cybersecurity, usability, and AI/ML-related risks
• Document-driven collaboration with subject matter experts in the risk management process
• Result: updated, regulatorily sound risk management file

Requirements

• Several years of practical experience in risk management for medical device software / SaMD
• Confident handling of ISO 14971 and IEC 62304
• Experience with design controls and regulatory documentation
• Experience in handling complex software-related risks (algorithmic, cybersecurity, usability, AI/ML)
• Business-fluent English (C2) as the team and documentation language

Nice to have

• Experience with AI/ML-based medical devices
• Domain knowledge in medical imaging or clinical workflow software
• Experience with cardiovascular applications
• Experience with risk analyses for medical devices close to implants

Project details

• Start: 2026-11
• Duration: 2 Monate
• Remote: hybrid
• Location: München, Deutschland, DE
• Languages: German