Job description

Senior Systems Risk Engineer

Oxford, UK

Job Title: Senior Systems Engineer (Risk)

Employment Status: Full Time, Perm

Practice: Systems

Location: Oxford

Salary: Competitive

Company:

Do you want to make a difference while advancing your career? Come join Osler.

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.

Desirable:

• Experience working within an ISO 13485 quality management system in medical device / IVD product development.
• Experience working to ISO 14971 medical device / IVD risk management regulatory requirements, including developing and modifying risk management documentation.
• Systems Engineering qualifications, including INCOSE certification.
• Experience in developing products that include fluidics and electrochemistry aspects.
• Experience in building system architecture and creating system architecture description accumulated via developing complex mechatronics product.

Benefits:

We offer a competitive benefits package, with a focus on health and well-being - further supporting the belief in our mission to enable anyone, anywhere, to access, understand and act on their health.

• 25 days holiday + bank holidays and a Christmas closure.
• Annual Learning & Development budget 4% of your salary.
• 12 days of Learning leave.
• 4% matched pension.
• £500 Well-being allowance.
• Private Medical Insurance - (includes subsidised gym memberships).
• 24/7 access to a GP.
• Life Assurance - x4 annual salary.
• Income Protection - 75% of your basic annual salary.
• Private Travel Insurance.
• Annual eye tests.
• Cycle to work scheme.
• Travel to work loan scheme.
• Relocation assistance.
• Volunteering leave.
• Give as you earn - pre-tax salary donations to any UK charitable organisation.
• Quarterly Team Building events and social events.
• Enhanced maternity/paternity.

There is no perfect candidate, and no single person can do it all, but if this sounds like you, or what you could be and you're looking for somewhere to thrive; we want to hear from you.

We look forward to receiving your application. If you have any questions, please contact talent@oslerdiagnostics.com