Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies
Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
We are looking for an enthusiastic and experienced Human Factors Engineer to support the development of new drug device combination products and oral solid dose products. Do you enjoy a challenging role with the opportunity deliver robust products that improve the patient experience and can give them access to life changing medicines from the comfort of their own home? The Human Factors Engineer is part of a dynamic and growing team that are key to delivering an expanding portfolio of injectable devices and more, used for pharma and vaccine drug products.
The role is to be based at our client's R&D site in Ware, Hertfordshire UK.
Responsibilities:
* Provide inputs for human centred design engineering for a range of projects across all phases of development
* You will effectively communicate your work to the wider development team and stakeholders.
* You will be involved in problem solving and utilisation of different strategies to support resolution of design, risk and regulatory challenges.
* Support the execution of early patient handling studies (formative studies), identification and maintenance of user needs, conducting user related risk assessments, planning and execution of design validation activities
* Ensure user needs are considered early and continuously throughout the design process
* Support the interface between the external vendors and the Human factors Team
* Management of external HF vendors
* Support the development and population of the Design History File as it pertains to design Validation
* Author sections of regulatory files
Requirements:
Education/Experience:
* Graduate in Mechanical Engineering, Biomedical Engineering or related degree (i.e: Physchology).
* 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 on the development, manufacture and integration of end user inputs (user needs and risk related scenarios) of medical devices/combination products.
* Working experience in product development and design validation as well as in the regulatory pathways for combination products is a must e.g. 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 devices/combination products design recommendations
* Excellent written and verbal communication skills as well as great attention to detail
* Strong time management/organisational skills
* Evidence of team working skills 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 above, and ultimately 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