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

The following challenges await you:

• In this role, you will play a key part in ensuring that our product development activities meet the highest standards of quality, compliance, and patient safety.


• You will serve as the R&D Subject Matter Expert for Risk Management and Design Assurance, providing expert guidance across development projects.


• You will support and advise cross-functional development teams in the application of ISO 14971 Risk Management principles and ISO 13485 Design Control requirements.


• You will review Risk Management Files, Design & Development Files (DDFs), and related documentation to ensure compliance, traceability, and completeness throughout the product development lifecycle.


• You will partner with project teams during design reviews and key development milestones, helping to identify risks and ensure robust design practices.


• You will act as the go-to expert and escalation point for complex Risk Management and Design Control topics.


• You will collaborate closely with Engineering, Quality, Regulatory Affairs, Clinical, and Operations teams to drive successful product development outcomes.


• You will develop and deliver training, mentoring, and coaching initiatives to strengthen organizational knowledge and capabilities in Risk Management and Design Assurance.


• You will contribute to the continuous improvement of development processes, tools, and documentation practices, helping to enhance efficiency, quality, and compliance across the organization.

Your profile: 

• Bachelor degree in engineering or related field required; master’s degree in Engineering or related technical field preferred,

• 5 years of experience in a regulated medical device environment required,

• 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 skills and the ability to influence cross-functional teams,

• Customer-focused mindset with the ability to work collaboratively across functional groups,

• Must be highly organized and able to manage multiple projects concurrently,

• Strong independent problem-solving skills and active work to coach others in this area. 

• Must possess strong written and verbal communication skills in English and proficient in MS Word, Excel and Minitab.