Senior Design Verification Engineer

1 month ago

Oxford, Oxfordshire, United Kingdom OSI Full time
{"title": "Senior Design Verification Engineer", "description": "Job Summary

We are seeking a highly skilled Senior Design Verification Engineer to join our team at OSI. As a key member of our design verification team, you will be responsible for driving and coordinating design verification activities across our product system, ensuring that our medical devices meet the highest standards of quality and regulatory compliance.

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
Requirements
  • 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
  • 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 OSI
  • Experience in implementing CLSI guidelines for the Analytical Validation of IVD assay performance
What We Offer
  • Competitive salary and benefits package
  • Opportunity to work on cutting-edge medical devices
  • Collaborative and dynamic work environment
  • Professional development and growth opportunities
How to Apply

If you are a motivated and experienced Senior Design Verification Engineer looking for a new challenge, please submit your application, including your resume and a cover letter, to us.

", "lang_code": "en"}

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