Human Factors Engineer

Job Ref: J31746
Sector: Engineering
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 02 May 2019
  • Cambridge, Cambridgeshire, England, UK Cambridge Cambridgeshire UK CB21 6GP
  • Competitive
    ANNUM
  • Satnam.Kour Kour
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Job Description:

Contract Human Factors Engineer A contract Human Factors Engineer role exists reporting into the Device Centre of Excellence group (known as DCoE) based in Cambridge UK. DCoE is Pfizer's global drug delivery device team who engage in projects across all business units and therapy areas within Pfizer's global network. A core activity within device development is management and execution of Human Factors Engineering activities for drug delivery system projects and compiling of related documentation for product regulatory submissions. The requirement is for a full time, office-based Human Factors Engineer and the role is based the DCoE office in Grant Park, Cambridge UK. The specific requirements for the role are as follows: Core role requirements * To work with Pfizer drug product teams, external design companies and human factors vendors in developing and ensuring timely execution of human factors engineering deliverables including project managing the supply, assembly and testing of materials for use in HF studies * To assist in the generation of human factors regulatory documentation associated with Pfizer devices * To provide support for the assessment and management of suppliers for human factors, and compliance issues related to the use of devices in the hands of users * To provide input and support for generation and change control of all Pfizer device Instructions for Use (IFU) documentation * To provide device usability input/support to device design inputs and HF study feedback and/or recommended mitigation actions into the DCoE design group and external device design authorities * To provide input into risk management activities related to assigned projects * To provide guidance to Pfizer personnel on all human factors engineering matters * Excellent written English skills * Strong ability to develop concise prose suitable for worldwide healthcare regulatory authorities * Comfortable working with all levels of the organisation * Strong attention to detail General requirements * Ability to work with multiple projects * Ability to understand medical device technical language * Capability to adhere to strict deadlines and prioritise work load under pressure * Ability to work on own and use initiative where required, or as part of a team Skills and Experience * Experience with Human Factors Engineering, ideally for combination products with devices * Excellent project/time management skills * Excellent IT skills essential - PC literate (rather than Macintosh) with good experience with typical Microsoft Office applications including MS PowerPoint * Minimum 3 years relevant experience Desirable but not essential skills /experience * Advanced qualification in Human Factors/Usability or associated faculty * Appreciation for pharmaceutical/medical device regulatory requirements * Background in a medical field

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01/06/2019 09:46:32
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