LUMA Vision is a start-up based in Dublin (Ireland) and Munich (Germany) developing cutting edge innovative imaging technologies to significantly advance healthcare and solve global unmet clinical needs. With creativity, passion, and focus, we apply our best-in-class engineering and design capabilities to create new hardware, software, and data science technologies.

We are looking for an experienced, enthusiastic, and multidisciplinary Senior Risk Management Specialist to join our highly skilled team. LUMA Vision is developing a state-of-the-art Intracardiac imaging system. The system, known as VERAFEYE, incorporates Hardware (Mechanical and electronic), Software (embedded and application based), and Algorithmic development.

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. As part of your role you will oversee the risk management process of customized software and hardware and play a critical role in a startup environment with a dynamic group of innovators, shaping the future of imaging in healthcare.

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.
• Support the planning and execution of verification and validation activities, with an emphasis on the demonstration of effectiveness of risk controls.
• Suggest, contribute, and champion initiatives to improve the risk management activities and design control procedures.
• Familiarity with new product introduction/ development (NPI)/ NPD).
• Exhibit a great attitude as a team player who excels in a demanding start-up environment.
• Understand the company’s quality policy and quality system requirements applicable to tasks.

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.

LUMA Vision is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, disability, religion/belief, sexual orientation, or age.

Would you like to become part of our team? We would love to hear from you and look forward to receiving your CV and cover letter.