About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2023 totaled $12.8 billion. To learn how we can supercharge progress for you, visit hcltech.com. Website -

Job Details :

• 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.
• 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.
• 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 development methodologies, especially as they relate to the application of Human Factors, Usability Engineering Principles and Risk Management.