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Senior Software Validation & Verification Engineer

Premium Job From Real Staffing
Recruiter: Real Staffing
Listed on: 13th November
Location: Macclesfield
Salary/Rate: £60,000 - £80,000
Type: Permanent
Start Date: ASAP

Our client is a fast growing international medical device company searching for an experienced Senior Software Verification & Validation engineer to ensure products maintain the highest levels of standards (SDLC) and compliance (IDVR).

The Senior Software Verification & Validation Engineer will perform essential assessments of the state, quality and completeness of our and OEM's design history files. You will play a key role in building Verification and Validation processes; working on new and existing products particularly in the digital pathology arena and as always, exceeding customer's expectations.

Role

  • Provide subject matter expertise in the following areas: IEC62304:2006 SDLC requirements; Software V&V requirements
  • Ensure industry best practices are integrated into software remediation activities
  • Perform the necessary gap analysis of DHF items to satisfy the FDA's requirements for Guidance for Software, IEC62304:2015 and FDA Cybersecurity Safety for 510(k) regulatory submissions
  • Create files for existing and OEM instrument's software including planning, architecture, design & testing, configuration management etc.
  • Recognize necessary links to the Risk Management process compliant to ISO14971:2019 and creates supporting files where required
  • Create a strategy for our product portfolio and execute the plan, demonstrating state of the art and compliance of software
  • Report validation metrics
  • Work with the medical devices QMS 21 CFR 820.30 and ISO 13485:2016 requirements

Skills:

  • Knowledge of IEC 62304:2006, GAMP5/CFR Part 11/Annex 11, ISO14971:2019, IEC62366-1:2015, FDA Guidance for Software Development, FDA Guidance for Cybersecurity
  • Software DHF assessments and remediation execution experience
  • Remediating legacy products for 62304 and IVDR/MDR
  • Proficiency with Software Development Life Cycle activities
  • Ability to create and execute software validation elements and processes
  • Software quality assurance experience specifically for medical devices
  • Ideally knowledge of Cloud Computing in GxP environment
  • Familiarity with Atlassian products for tracking development of software and for testing e.g. TM4J
  • Experience with assessing software portability, reliability, functionality and usability
  • Adherence to a stage gated quality system

Education:

Ideally a degree in a Computer Science or equivalent medical device experience

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

Contact Name: Anjam Khan
Reference: TJ/3386/RE-33599136_1605288915
Job ID: 2871360



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