Risk Management & Design Assurance Subject Matter Expert (m/f/d)

In this role you will serve as the R&D expert for Risk Management and Design Assurance, guiding development projects to meet quality, compliance, and patient-safety standards. You will partner with cross-functional teams to apply ISO 14971 and ISO 13485 requirements, review critical files, and support design reviews. You will drive robust risk management practices, coach others, and contribute to process improvements across development activities. This role offers the chance to shape the compliance and quality trajectory of medical devices at Heraeus Medevio. You’ll work in a collaborative, learning-focused environment aimed at improving lives through medical innovation.

• guide application of ISO 14971 risk management and ISO 13485 design control across development projects
• review Risk Management Files (RMF) and Design & Development Files (DDFs) for compliance and traceability
• participate in design reviews and major development milestones to identify risks and ensure robust design practices
• act as escalation point for complex risk management and design control topics
• collaborate with Engineering, Quality, Regulatory Affairs, Clinical, and Operations
• develop and deliver training, mentoring, and coaching on risk management and design assurance
• contribute to continuous improvement of development processes, tools, and documentation practices

• Bachelor degree in engineering or related field; master’s preferred
• 5 years in a regulated medical device environment
• Solid understanding of ISO 13485, ISO 14971, FDA and EU MDR requirements
• Experience with medical device product development and Design Control processes
• Strong analytical and problem-solving skills
• Excellent communication and ability to influence cross-functional teams
• Customer-focused mindset and ability to collaborate across functions
• Highly organized with ability to manage multiple projects
• Strong written and verbal English; proficient in MS Word, Excel, and Minitab

• communication skills
• cross-functional collaboration
• problem-solving
• ISO 13485
• ISO 14971
• FDA requirements