Risk Management & Design Assurance Subject Matter Expert (mfd)
Job Location:
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 2200 employees worldwide together we will meet tomorrows 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; masters 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.
Curious Apply now!
We are interested in finding the best candidates and they may come from a nontraditional background. So please dont hesitate to apply even if you arent an exact fit. We look forward to getting you started on your employment journey with Heraeus Medevio!
Any further questions
Our Recruiting Team Heraeus Medevio is happy to assist you by email: . Or visit us at .
About Company
The Heraeus Group is a broadly diversified and globally leading family-owned technology company, headquartered in Hanau, Germany. The company’s roots go back to a family pharmacy started in 1660. Today, Heraeus bundles diverse activities in the Business Platforms Metals and Recycling, ... View more
