Overview
Join to apply for the Human Factors Engineer - client dedicated role at Thermo Fisher Scientific.
Location: Ware, Hertfordshire, UK (client site).
Work schedule: Standard (Mon-Fri).
Responsibilities
* Provide inputs for human centred design engineering for a range of projects across all phases of development.
* Effectively communicate your work to the wider development team and stakeholders.
* Engage in problem solving and utilise different strategies to support resolution of design, risk and regulatory challenges.
* Support the execution of early patient handling studies (formative studies), identify and maintain user needs, conduct user-related risk assessments, and plan and execute design validation activities.
* Ensure user needs are considered early and continuously throughout the design process.
* Support the interface between external vendors and the Human Factors Team; manage external HF vendors.
* Contribute to the development and population of the Design History File as it pertains to design validation.
* Author sections of regulatory files.
Education/Experience
* Graduate in Mechanical Engineering, Biomedical Engineering or related degree (e.g.: Psychology).
* Practical experience and knowledge of human factors and usability regulatory framework, including FDA guidance, IEC 62366 and ANSI/AAMI HE75, and expectations for medical devices/combination products.
* Experience developing, manufacturing and integrating end-user inputs (user needs and risk-related scenarios) for medical devices/combination products.
* Experience in product development and design validation as well as regulatory pathways for combination products (global submissions, agency interactions, and authoring dossiers).
* Experience with integration of risk factors and user inputs into device design.
Skills/Abilities
* Ability to analyse and summarise data and translate them into design recommendations for devices/combination products.
* Excellent written and verbal communication skills and strong attention to detail.
* Strong time management and organisational skills.
* Evidence of teamwork and flexibility.
* Experience with combination product and/or parenteral device development would be beneficial.
Our 4i Values
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values and wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
Job Details
* Seniority level: Not Applicable
* Employment type: Full-time
* Job function: Research and Science
* Industries: Pharmaceutical Manufacturing and Biotechnology Research
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