Senior Systems Risk Engineer

Description:

We are a UK diagnostics company whose purpose is to enable anyone, anywhere, to access, understand, and act on their health, to live healthier, happier, and longer lives.

We are realising this through the development of the Osler Origin – a 'portable lab' capable of performing a wide range of testing, with lab-quality performance, in a portable, rapid, low-cost, and easy-to-use manner. The Osler Origin will offer a wide portfolio of diagnostic tests and serve all major healthcare settings, globally.

The Osler Origin is powered by a portfolio of novel techniques and approaches for sample addition, microfluidic sample preparation, and electrochemical biosensing, and Osler was formed out of the University of Oxford in 2017, following decades of research.

Having recently completed an $85m Series C fundraise, we are now entering a growth phase, where we are scaling our team as we take the Osler Origin product through regulatory activities, and towards market launch.

Join us and help build a better future.

Key Responsibilities:
 

• Create and maintain system and subsystem requirements, including change control using Codebeamer X.
• Plan, coordinate and perform risk management activities in accordance with IVD regulatory standards, throughout the product development lifecycle.
• Provide guidance and support to other functional areas on the relevant risk management processes and procedures.
• Lead appropriate Cross Functional teams to review design changes and their potential impact on Risk management documentation.
• Plan, design, execute and report on system and subsystem level verification testing.
  
   

Skills & Experience:

Essential:
 

• Relevant requirements engineering, and requirements management experience accumulated via developing complex mechatronics product.
• Experience in product risk management processes, e.g., FMEA, FTA, Hazard Analysis, etc. accumulated via developing complex mechatronics product.
• Experience in planning, designing, performing, and reporting on verification testing accumulated via developing complex mechatronics product.
• Technical background in design, science and/or engineering with a minimum of BSc in a relevant subject.
• Coordination and facilitation across multi-disciplinary technical, commercial, quality and regulatory teams.
• Excellent written and spoken English, clear communication with all types of stakeholders.
• Highly competent in Word, Excel, PowerPoint, etc.