Senior Design and Verification Engineer

3 weeks ago

Oxford, Oxfordshire, United Kingdom OSI Full time
{"title": "Senior Design and Verification Engineer", "description": "Join Our Team as a Senior Design and Verification Engineer

At OSI, we are seeking a highly skilled Senior Design and Verification Engineer to drive and coordinate Design Verification activities across our product system.

As a key member of our team, you will work collaboratively with development scientists and engineers to determine the methods and evidence required to verify that a product design meets its requirements.

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

We offer a competitive benefits package, with a focus on health and well-being, including:

  • 25 days holiday + bank holidays and a Christmas closure
  • Yearly Learning & Development budget 4% of your salary
  • 12 days of Learning leave
  • \u00a3500 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

We are an equal opportunities employer and welcome applications from all qualified candidates.

", "company": "OSI", "location": "Oxford - hybrid", "job_type": "Full-Time, Permanent"}

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