Job Description

Job Summary:
Follow a human factors engineering process as required by international and national regulatory bodies and design and conduct appropriate evaluations to validate new medical devices and changes to currently fielded medical devices.

Education:
Required: Bachelor's Degree in Human Factors / Industrial Design / User Experience Design/ Cognitive Psychology/ Biomedical Engineering / Biomechanical Engineering or related discipline.
Preferred: Master's degree in Human Factors / Industrial Design / User Experience Design/ Cognitive Psychology/ Biomedical Engineering / Biomechanical Engineering or related discipline.

Experience: 4-6 years of experience in Human Factors / Usability engineering and / or Product Design, Development experience with medical devices.

Key Responsibilities:
Support Project Managers and Research & Development teams in establishing Human Factors (HF) and Usability-related requirements for new and existing products, in the Medical Devices domain. HCL-STRIDE Job Description: Usability Engineer / Human Factors Engineer Version 1.0 HCLT Internal
Serve as end-user / customer advocate to deliver medical devices that are safe & effective, easy to use, not prone to user error, and that entail a low burden of care.
Assist in ensuring that design, testing, documentation and regulatory submittal activities are fully compliant with and reflect best-practices with respect to the implementation of all relevant HF & Usability-related standards (ISO 62366-1, 2015. ISO 62366-2, 2016 and He 75 etc.) and guidance documents.
Collaborate with Project Management, Industrial Design, Mechanical Engineering, Hardware Engineering and Software Engineering teams in identifying intended users and use environments, as well as potential use-related hazards; determine product use cases and identify critical user tasks; draft use specifications and uFMEAs.
Collaborate with internal & external parties in planning, structuring, recruiting for, and executing formative and summative usability evaluations.
Draft usability reports and other documentation needed to support regulatory filings.
Requirements:
Strong understanding of medical device product design and regulatory processes.
Excellent communication and writing skills.
Experience with medical device design and development processes that conform to standards including: IEC 62366, IEC 62304, ISO 14971, HE 75 (required). Exposure to medical device design and development processes that conform to standards including: IEC 60601and ISO 13485 (good to have).
Understanding of system, electrical, and mechanical design, as well as software integration.
Prior experience with complex electro-mechanical systems is preferred.
Experience in working with third-party service providers and external certification laboratories.
Experience in structuring, recruiting for, conducting, and reporting on formative and summative usability evaluations, especially involving medical devices.
Experience in the application of best-practice product HCL-STRIDE

Job Description: Usability Engineer / Human Factors Engineer Version 1.0 HCLT Internal development methodologies, especially as they relate to the application of Human Factors, Usability Engineering Principles and Risk Management

Job Tags

Similar Jobs