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

Contract Medical International GmbH HRdirekt; Dresden; On-site; EUR 90,000 - 120,000; Full time

Job summary

Heraeus Medevio is seeking an experienced expert in Risk Management and Design Assurance to ensure quality and patient safety across medical device development programs.

You will act as SME for risk management, apply ISO 14971 and ISO 13485 requirements, review RM and DDFs, and collaborate with engineering, quality, regulatory, clinical, and operations teams to drive successful outcomes.

Qualifications

• 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 ability to coach others
• Strong written and verbal communication skills in English; proficient in MS Word, Excel, and Minitab

Responsibilities

• Ensure product development activities meet the highest standards of quality, compliance, and patient safety
• Serve as the R&D Subject Matter Expert for Risk Management and Design Assurance across development projects
• Support cross-functional development teams in applying ISO 14971 Risk Management principles and ISO 13485 Design Control requirements
• Review Risk Management Files, Design & Development Files (DDFs), and related documentation for compliance and traceability
• Partner with project teams during design reviews to identify risks and ensure robust design practices
• Act as go-to expert and escalation point for complex Risk Management and Design Control topics
• Collaborate with Engineering, Quality, Regulatory Affairs, Clinical, and Operations to drive development outcomes
• Develop and deliver training, mentoring, and coaching to strengthen capabilities in Risk Management and Design Assurance
• Contribute to continuous improvement of development processes, tools, and documentation

Skills

ISO 13485

Risk Management

Design Control

Regulatory affairs

Cross-functional collaboration

Education

Bachelor degree in engineering

Master’s degree preferred

Tools

MS Word

Excel

Minitab

Job description

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

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.