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

As a Subject Matter Expert for Risk Management and Design Assurance at Heraeus Medevio, you will ensure that product development activities meet the highest standards of quality, compliance, and patient safety. You will provide expert guidance across development projects and serve as a key escalation point for complex topics.

Main Tasks:

• Provide expert guidance on ISO 14971 Risk Management principles and ISO 13485 Design Control requirements to cross-functional teams.
• Review Risk Management Files, Design & Development Files (DDFs), and related documentation for compliance, traceability, and completeness.
• Partner with project teams during design reviews and milestones to identify risks and ensure robust design practices.
• Collaborate with Engineering, Quality, Regulatory Affairs, Clinical, and Operations teams to drive successful outcomes.
• Develop and deliver training, mentoring, and coaching initiatives to strengthen organizational knowledge.
• Contribute to the continuous improvement of development processes, tools, and documentation practices.

Requirements:

• Bachelor degree in engineering or a related field (Master’s degree in Engineering or a related technical field preferred).
• At least 5 years of experience 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 independent problem-solving skills.
• Excellent written and verbal communication skills in English.
• Proficiency in MS Word, Excel, and Minitab.
• Ability to manage multiple projects concurrently and influence cross-functional teams.

Work Conditions:

• Full-time employment.
• Direct hire contract.