Job description

Senior Design Verification Engineer

Oxford

Job Title: Senior Design Verification Engineer

Employment Status: Full-Time, Permanent

Practice: Programme Delivery

Location: Oxford - hybrid

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.

We now have an exciting opportunity as a Senior Design Verification Engineer, where you will Drive and coordinate Design Verification activities across the product system.

Join us and help build a better future.

Key Responsibilities:

• Drive and coordinate Design Verification activities across product system, including mechanical, electrical and software technical areas, in accordance with IVD regulatory standards​
• Work collaboratively with development scientists and engineers to determine the methods and evidence required to verify that a product design meets its requirements​
• Author Design Verification plans, protocols and reports and support technical teams to create verification documentation​
• Develop and manage complex product build and test schedules to ensure efficient use of materials and resources both internally and externally​
• Act as a gatekeeper for Design Verification, ensuring product design requirements are clearly defined and verifiable
• Ensure design outputs are correctly specified and documented to support verification; Ensure that the required design verification deliverables are created to support completion of the design verification stage

• Design Assurance – act as an interface between all areas of design control e.g. design inputs, design outputs, risk management, design verification, DHF/DMR creation, quality control

Skills & Experience:

Essential

• Experience working within an ISO 13485 QMS in medical device / IVD product development including all aspects of design control​
• Coordination and facilitation across quality, regulatory and multi-disciplinary technical teams​
• Strong technical documentation reading and writing skills, including presenting of data in meaningful and relevant formats.
• Experience working with complex electromechanical products and awareness of test methods for mechanical, electrical and software requirements​

Desirable

• Experience in leading Design Verification activities for IVD / medical devices​
• Excellent metrology knowledge including performing Gauge R&R studies/MSA​
• Working experience with ALM/PLM software systems (e.g. Codebeamer, Windchill), preferably with administrator privileges, confidence to become a system expert within Osler
• Experience in implementing CLSI guidelines for the Analytical Validation of IVD assay performance​
• Experience in medical device software development

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
• Yearly 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