Human Factors Engineer ( 12 month maternity cover)

Vision RT Ltd.•Nashua, NH

About The Position

Working closely with Product Owners, Product Managers and Development team, the Usability Engineer will be responsible for user testing of the products in the Vision RT portfolio. The aim of this role will be to incorporate human factor principles in the design of Vision RT products to minimize errors, ensure efficient use and learnability of the products and avoiding human factor related issues that could influence patient and user safety.

Requirements

Holds a degree or equivalent qualification in Usability Engineering, Engineering or similar subject, or can demonstrate equivalent work experience. More than 3 yearsâ experience in a medical device development or compliance engineering role.
Demonstrable experience in developing usability risk management documents such as task analysis, task risk analysis, planning and executing formative and summative use risk evaluations.
Strong understanding of IEC 62366-1, IEC 60601-1-6 and IEC 14971, FDA Human Factors guidance.
Strong administration skills and attention to detail.
A critical thinker with good attention to detail and problem-solving skills as well as a demonstrable level of understanding of technical areas.
Ability to work independently and collaboratively, and ability to prioritise and plan tasks.
Ability to work in a fast-paced environment with multiple tasks/projects.
Competent in Microsoft Office products.
Fluent in written and spoken English.

Responsibilities

Document task analysis and identification of potential use errors. Recommend and document appropriate mitigations for identified use errors.
Collaborate with R&D and Product Risk Teams to design in mitigations for use errors that might result in user or patient harm.
Collaborate with Development and User Experience Teams to create intuitive designs which minimise user mistakes.
Work with downstream stakeholders to plan, coordinate and lead user feedback, formative and summative studies in line with the product development roadmap.
Analyse results from user studies, compile reports and work with stakeholder groups to troubleshoot use errors identified in the field and feed learnings back into development of new and updated products and features.
Gather and analyse data from post-market surveillance activities to maintain current documentation on known use errors and likelihood of occurrence, identify emerging use-related risks and suggest potential risk controls.
Document all usability engineering activities in line with IEC 62366-1, IEC 60601-1-6 and other applicable international regulations, standards and guidance on medical device usability.
Assist in maintaining procedures in line with international regulations, standards and guidance applicable to the company's products and activities in target markets.
Act as a Subject Matter Expert during internal and external audits. Support internal and external audits by Vision RTâ ms notified body and other third parties.
This role requires occasional UK and international travel.
Occasional evening and weekend work, depending on project deadlines.