Senior Design Verification Engineer

at  Osler Diagnostics

Job Title: Senior Design Verification Engineer
Employment Status: Full-Time, Permanent
Practice: Programme Delivery
Location: Oxford - hybrid
Salary: Competitive

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.co

• 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