Delivery Consultant @ Empresaria Group plc

Human Factors Engineer

Contract Duration: 12 months

Location: Cambridge, UK

Working Environment: Flexible, home and office based.

Role Summary:

A contract Human Factors Engineer role reporting into the Human Factors Team at the Devices Centre of Excellence (known as DCoE) based in Cambridge UK. DCoE is our client's global drug delivery device team who engage in projects across all business units and therapy areas within client'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.

Core role requirements:

• Work with client's 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.
• Provide device usability input/support to device design inputs and human factors study feedback and/or recommended mitigation actions into the DCoE design group and external device design authorities.
• Manage and document use-related risk related to assigned projects.
• Provide input and support for generation and change control of all client's device Instructions for Use (IFU) documentation.
• Assist in the generation of human factors regulatory documentation associated with client's devices.
• Provide guidance to personnel on all human factors engineering matters.
• Strong ability to develop concise prose suitable for worldwide healthcare regulatory authorities.
• Comfortable working with all levels of the organization.
• Strong attention to detail.

General requirements:

• Ability to work with multiple projects.
• Ability to understand medical devices and combination product technical language.
• Capability to adhere to strict deadlines and prioritise workload 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.
• Around 3 years of relevant experience.

Seniority level

Entry level

Employment type

Contract

Job function

Engineering, Research, and Science

Industries

Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Retail Health and Personal Care Products