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Senior Human Factors Engineer


Cambridge, MA
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Job Details

**Senior Human Factors Engineer** **Location: Cambridge**

**Job Purpose:**

+ To ensure assigned devices, associated labelling and packaging, and training (if applicable) are designed to be safe and effective for use by intended users within intended environments for all chosen markets

+ 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 for assigned devices

+ To assist in the generation of design validation and human factors regulatory documentation for assigned devices

+ To manage all interfaces with Human Factors vendors for assigned devices including project management of material supply to study sites

+ To provide guidance to Pfizer personnel on all human factors engineering matters


+ Generate and ensure approval of all Pfizer device human factors engineering documentation for assigned devices

+ Provide input and support for risk management activities related to assigned devices

+ Provide device usability input/support to device design inputs and device design specification

+ Manage all human factors (HF) activities associated with HF vendors, including on boarding of HF vendor, generation of study brief, attainment of HF vendor proposals, assignment of HF vendor, providing all relevant materials and documentation, management of HF studies, and generation and approval of associated protocols and reports

+ Project manage the supply, assembly and testing of materials for use in HF studies and associated documentation

+ Report any adverse findings or adverse events witnessed at HF studies and ensure appropriate action

+ Ensure timely execution of HF studies for assigned projects

+ Provide HF study feedback and/or recommended mitigation actions into the DCoE design group and external device design authorities

+ Provide input and support for generation of assigned Pfizer device Instructions for Use (IFU), device labelling and packaging

+ Design and ensure full change control for IFU documentation where applicable for assigned projects

+ Assist with all design validation activities for assigned projects including clinical study support, complaints analysis and justifications for not performing human factors where applicable.

+ Support the generation of device regulatory submission data

+ Provide input into risk management activities related to assigned projects ensuring risk files are aligned with human factors activity and feedback

+ Assist in the application of HF engineering principles and controls for all device development projects

+ Support and conduct human factors research to augment present and future device projects including in-house laboratory testing and external research with the support of contract staff/vendors

+ Support continuous improvement activities as they relate to design validation/human factors

+ Support internal and external audits of the DCoE Quality System as they relate to design validation/human factors.

**Role Development:**

+ Develop technical expertise in device design control, risk management, human factors engineering, quality systems and in the regulatory requirements for devices

+ Develop interfaces across Pfizer, developing common approaches to human factors principles across a range of device technologies

+ Develop greater understanding of the role of DCoE and the Pharmaceutical Sciences organisation in the drug development process and its interfaces with other key lines e.g. Pharmaceutical Sciences Project Teams

+ Develop technical expertise in specific area of involvement and become recognised as an increasingly competent technical contributor

+ Expand and develop engineering and scientific skills relevant to combination products and medical devices

+ Acquire understanding of specific drug delivery technologies for various dosage forms from in-vitro testing to clinical trials and commercialisation

+ Generate opportunities to develop communication and negotiating skills to operate effectively in a multidisciplinary environment, both internal and external to Pfizer

+ Develop effective team working skills and personal skills to ensure implementation of strategies and deliverables.

**Educations, Skills and Experience:**

+ Degree or equivalent in relevant subject.

+ Experience in a human factors role

+ Background of working in teams in the development or trouble shooting of equipment, devices or manufacturing processes by means of human factors evaluations and logical problem solving.

+ Experience of working in a rigorous quality system

+ Excellent IT skills PC literate (rather than Macintosh) with good experience with typical Microsoft Office applications including MS PowerPoint

+ Thorough understanding of Human Factors Engineering

+ Able to learn and apply established procedures in a reliable and consistent manner.

+ Able to anticipate what information is required by their colleagues and to disseminate it actively and efficiently.

+ Able to prepare and present data to technical colleagues in a succinct and informative way

+ Position located in Cambridge, UK. Able to travel or relocate to Cambridge area

+ Able to travel within the EU and oversees for work

**Closing Statement**

This position holds a Global Job Level R5 and UK Grade 09.

Please do not submit paper or e-mail applications.

In line with good development planning, colleagues should discuss their suitability and/or readiness for a vacancy with their line manager prior to application. Colleagues are required to inform their manager if they are invited to attend interview. Where a line manager is not able to support an application either for suitability, readiness or business reasons, and a colleague continues to make an application, it is possible that an offer may not be made or may be withdrawn.

All applicants must have the relevant authorisation to live and work in the UK.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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