Senior Risk Management Specialist

The Senior Risk Management Specialist will be responsible for developing, maintaining, and supporting the company's Risk Management file. You will be part of the development team of our imaging system, to find the best possible solutions to address challenges and implement a risk-based approach to medical device development.

Key responsibilities for this role include

• Apply technical excellence and leadership for complex systems to achieve safe and effective designs for new and existing product platforms.
• Drive Risk Management activities, including the incorporation of applicable medical standards.
• Prepare, present, and lead formal/informal reviews of results, deigns, and analyses, and drive alignment with peers, project team, and cross-functional stakeholders.
• Develop and update Design History File records to support both Quality and Regulatory documentation.
• Follow design control processes while generating and reviewing Risk Management deliverables, including:
  • Risk Management Plan;
  • Known and foreseeable hazards;
  • Risk Analysis (hardware, software, cybersecurity, usability, interoperability, etc.);
  • Warning labeling traceability;
  • Traceability Report (hardware, software, cybersecurity, usability, interoperability, etc.);
  • Risk Management Report;
  • Risk Controls;
  • Risk Policy;
  • Harms List.

What you offer

• Demonstrable understanding and application of Design Controls per 21 CFR 820.30 and Risk Management per ISO 14971:2019.
• Demonstrable understanding and application of Design, Use and Manufacture risk-related analysis methodologies, including but not limited to FMEAs, FTAs and Medical Hazard Analysis.
• Hands-on mindset with problem-solving skills and great attention to detail also while multitasking.
• Ability to work in cross-functional teams that span global operations
• Technical understanding of complex technical systems involving mechanical and mechatronic systems, electronics, acoustics, software, and signal processing.
• Experience with intravascular catheter or minimally invasive device design and development is a plus.
• Demonstrated experience in leading internal and external development resources to achieve product development goals.
• Strong work ethic with a team-oriented mindset. Previous Startup experience is a plus.
• Excellent communication skills in English
• BE/BEng degree in biomedical, mechanical, electrical, systems or software engineering, post graduate is a plus.

What we offer

• Working in a start-up developing cutting edge imaging systems improving healthcare.
• Becoming part of a dynamic, multi-national team of highly skilled individuals with a very strong focus on team culture and individual development.
• A permanent contract in an award-winning start-up.
• Flexible working environment and an international culture as well as offices in Germany and Ireland.