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:
1. Drive and coordinate Design Verification activities across product system, including mechanical, electrical and software technical areas, in accordance with IVD regulatory standards
2. Work collaboratively with development scientists and engineers to determine the methods and evidence required to verify that a product design meets its requirements
3. Author Design Verification plans, protocols and reports and support technical teams to create verification documentation
4. Develop and manage complex product build and test schedules to ensure efficient use of materials and resources both internally and externally
5. Act as a gatekeeper for Design Verification, ensuring product design requirements are clearly defined and verifiable
6. 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
7. 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
8. Experience working within an ISO 13485 QMS in medical device / IVD product development including all aspects of design control
9. Coordination and facilitation across quality, regulatory and multi-disciplinary technical teams
10. Strong technical documentation reading and writing skills, including presenting of data in meaningful and relevant formats.
11. Experience working with complex electromechanical products and awareness of test methods for mechanical, electrical and software requirements
Desirable
12. Experience in leading Design Verification activities for IVD / medical devices
13. Excellent metrology knowledge including performing Gauge R&R studies/MSA
14. Working experience with ALM/PLM software systems (e.g. Codebeamer, Windchill), preferably with administrator privileges, confidence to become a system expert within Osler
15. Experience in implementing CLSI guidelines for the Analytical Validation of IVD assay performance
16. 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.
17. 25 days holiday + bank holidays and a Christmas closure
18. Yearly Learning & Development budget 4% of your salary
19. 12 days of Learning leave
20. 4% matched pension
21. £500 Well-being allowance
22. Private Medical Insurance - (includes subsidised gym memberships)
23. 24/7 access to a GP
24. Life Assurance - x4 annual salary
25. Income Protection - 75% of your basic annual salary
26. Private Travel Insurance
27. Annual eye tests
28. Cycle to work scheme
29. Travel to work loan scheme
30. Relocation assistance
31. Volunteering leave
32. Give as you earn - pre-tax salary donations to any UK charitable organisation.
33. Quarterly Team Building events and social events
34. 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