Jobs

Software Verification Team Lead (Medical) - UK

Software & Electronics
Ref: 287 Date Posted: Friday 08 Feb 2019
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We are looking for proactive, talented, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our Clients company.

 

Role: Permanent

 

Role Description / purpose

 

Reporting to the Head of Software Engineering and working as part of the engineering team, the role will be responsible for driving the verification and validation Point of Care (POC) instrument software and associated tools. This role will require the capability to perform and manage the verification and validation of software used in the creation of a medical device as well as to build and then manage a software test team to facilitate delivery of the fully verified and validated product software feature set. 

 

This role will be based out of the Thurleigh office in Bedfordshire.

 

Key roles and Responsibilities

  • Develop and maintain a suitably sized and capable software test team to deliver the required project Verification and Validation software elements.
  • Line management of the software test team.
  • Ability to define and execute the required verification activities needed to demonstrate the software design has met specification.
  • Create the required V&V QMS documentation.
  • Review and critique software QMS documentation developed by other team members (Specifications, RA, test plans, test protocols, test results).
  • Responsible for the verification and validation of medical device embedded systems software and any associated project software development tools/utilities.
  • Verification of 3rd party software used as part of the software application, e.g. RTOS, GUI middleware, low level device drivers, bootloaders/firmware upgrades, LCD Touchscreens.
  • Ensure the software V&V activities are compliantly completed in line with the required project timelines.

 

Essential skills

  • Degree qualified in software engineering or relevant equivalent field
  • A good understanding of the medical Software Lifecycle and how software verification/validation fits into this.
  • Ability to create and maintain Software V&V plans describing the testing methods and approaches required to verify/validate the allocated software applications, in the most time effective manner.
  • Ability to translate software requirements or design information into test scenarios and protocols.
  • Intimate practical knowledge of both functional and non-functional software testing using black box and white box testing methods for unit, integration and system level testing for embedded software or supporting PC based software applications.
  • Ability to create and maintain software test protocols and software verification/validation summary reports.
  • Expert in the set up and use of defect tracking tools/methods. (e.g. Jira)
  • Competent in the use of software configuration management tools (e.g. GitHub)
  • Expert in the installation, set up and use of continuous integration test and build systems. (e.g. Jenkins)
  • Understanding and general familiarity with software developed for embedded systems or supporting PC based applications is essential.
  • A general familiarity with electronics hardware especially target boards used for software development and test.
  • Able to use design/debugging tools and instruments (e.g. oscilloscopes, multimeters, function generators, programmable power supplies, logic analysers, JTAG, IAR IDE, RS232 and USB interfaces).

 

Highly Desirable Skills

  • Knowledge of documentation generation to the standard required by the FDA and in compliance with 62304 is highly desirable.
  • Practical experience in software development (C/Asm/C#)
  • Knowledge of interrupt handling, bootloaders, flash operations and peripheral programming.

 

Non Technical Skills

  • Highly motivated individual that can demonstrate flexibility and a can do attitude.
  • Ensures a positive, productive and proactive relationship with a range of internal and external key stakeholders.
  • A quick learner with the desire and ability to attain the required information to enable verification and validation of the required software sub systems within the defined timescales.
  • Self driven, takes ownership, and is motivated to complete the objectives given.
  • Is an effective communicator, providing progress feedback on a regular basis and as required at project meetings to the Head of software engineering.
  • Ability to plan and organise your work in accordance with the overall objectives and required timelines via creation and maintenance of the software V&V sections of the overall project plan.
  • Demonstrates the ability to solve problems under conditions of uncertainty and ambiguity and is able to think strategically in times of pressure to drive toward the best solutions
  • Able to travel between company sites as needed (not expected to be frequent)

 



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