Senior Risk Manager

Senior Risk Manager (m/f/d) Munich or Dublin

WHO ARE WE?

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 truly global unmet clinical needs. With creativity, passion and focus, we apply our best-in-class engineering and design know how to create new hardware, software and data science technologies.

The position may be based in Munich or Dublin and reports to the Head of Hardware Systems. It is a hybrid role, with 3 days required on site. The Senior Risk Manager is responsible for developing, maintaining, and supporting the company's risk management files. This role is part of the development team of LUMA Vision imaging and navigation systems and imaging catheters, to address challenges and implement a risk-based approach to medical device development. The Senior Risk Manager has ownership of the risk management process of complex software controlled electro-mechanical systems, including hardware, embedded software, risks associated with the integration of artificial intelligence (AI) in medical devices and cybersecurity. The implantation of a risk-based approach covers all phases of the product lifecycle including research and development, product and process qualification, design validation, design transfer, clinical evaluation, product launch, post market risk analysis and monitoring and end of life.  This will require close work in multidisciplinary teams to facilitate the development and maintenance of the company's risk management files.

YOUR ROLE WILL BE

• 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, designs, 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:

o   Risk Management Plan;

o   Known and foreseeable hazards;

o   Risk Analysis (hardware, software, cybersecurity, usability, interoperability, etc.);

o   Warning labelling traceability;

o   Traceability Report (hardware, software, cybersecurity, usability, interoperability, etc.);

o   Risk Management Report;

o   Risk Controls;

o   Risk Policy;

o   Harms List.

• Support the planning and execution of verification and validation activities, with an emphasis on the demonstration of the effectiveness of risk controls.

• Suggest, contribute, and champion initiatives to improve the risk management activities and design control procedures.

• Lead post-market risk analysis and monitoring.

• Exemplify strong work ethics and a team-oriented mindset as necessary in a start-up environment.  

WHAT YOU OFFER

Education and Knowledge profile:  

• MUST: Have Bachelor or Master's Degree in engineering or related training background.

• MUST: 5+ years' experience in Risk Management or Quality / Regulatory within a regulated industry (e.g. medical, pharmaceutical, automotive, aerospace).  

• MUST: Demonstrable understanding and application of Design Controls per 21 CFR and Risk Management per ISO

• MUST: Demonstrable understanding and application of Design, Use and Manufacture risk-related analysis methodologies, including but not limited to FMEAs, FTAs and Medical Hazard Analysis.  

• MUST: Technical understanding of complex technical systems involving mechanical and mechatronic systems, electronics, acoustics, software, and signal processing.  

• MUST: Have knowledge of Design Controls. 

• MUST: Have experience working within a Quality Management System. 

• MUST: Have experience creating Risk items, Risk Controls, Traceability Matrices, Hazard Analysis, Risk Reviews, Plans and Reports.

• MUST: Technical understanding of complex technical systems involving mechanical and mechatronic systems, electronics, acoustics, software, and signal processing.

• MUST: Communication in English.

• MUST: Hands-on mindset with problem-solving skills and great attention to detail also while multitasking.

• MUST: Ability to work in cross-functional teams that span global operations.

• MUST: Have experience writing plans and reports. 

• SHOULD: Experience with intravascular catheter or minimally invasive device design and development.  

• SHOULD: Have knowledge of ultrasound imaging systems  

• SHOULD: Have experience working in a startup environment.

Soft Skills:  

·     MUST: Strong work ethics and a team-oriented mindset.  

·     MUST: Hands-on mindset with problem-solving skills and great attention to detail, while multitasking.  

·     MUST: Be able to work as part of a team.  

·     MUST: Be able to work independently.  

·     MUST: Be comfortable communicating with all levels of the organization.  

·     MUST: Be comfortable communicating cross-functionally with Quality, Regulatory & Clinical depts.  

·     MUST: Be able to present concepts, data and work to a broad company audience.  

·     SHOULD: Mentor more junior team members.

WHAT WE OFFER

·       Working on cutting edge imaging systems for the direct benefit of patients and 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 learning environment where you can extend and build upon your skills and interests.

·       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.  Please apply for the position