The role is to design, validate and optimize user interface/user-device interaction and assist throughout the medical device/combination product life cycle, from development through the regulatory submission process and post-market activity.
- Responsible for the usability engineering activities for drug delivery systems with direct responsibility of assessment of user interfaces, risk management, planning and overall execution of usability testing activities.
- Establish internal capabilities and external relationships needed for all HF & usability engineering needs of the organization.
- Ensure design, testing, documentation, and regulatory filing requirements are fully compliant to all human factors and usability engineering related guidance and standards.
- Collaborate with product engineering to identify intended users and use environments as well as potential use related hazards.
- Determine product use cases, carry out user task analyses, identify critical user tasks and assist in derivation of user requirements & technical specifications.
- Responsible for execution of usability engineering & HF deliverables for each development life cycle phase.
- Collaborate with internal and external partners in planning, structuring, recruiting for, and execute formative and summative evaluations.
- Work closely with different systems engineering & sub-systems team (mechanical & electronics) to understand overall system level architecture, user interface elements, identify critical safety and quality characteristics to develop usability test plan & protocols for execution.
- Prepare reports or presentations summarizing results or conclusions of human factors engineering or ergonomics activities, such as testing, investigation, or validation.
- Design and testing of device labelling and effectiveness of instructions for use (IFU), including warnings and caution statements.
- Responsible for risk management planning and documentation of HF/UE testing for inclusion in design history file.
- Atleast 3 years of experience in Human Factors/Usability engineering of medical devices (FDA Class II/III medical device experience desired).
- Experience with various HF methodologies such as ethnographic research, user group interviews, contextual inquiries, focus group discussions, technical assessments, user interface evaluation, task analysis, hazard analysis & risk assessments.
- Hands-on skills with the proven ability to execute formative and summative testing of complex medical devices/systems.
- Working knowledge on ISO/Regulatory/IEC standards such as IEC 62366, ISO 14971, ANSI/AAMI HE 75, ISO 13485, 21 CFR Part 820, 21 CFR Part 4, MDR.
- Experience working with external service providers and testing agencies.
- Experience in and demonstrable contribution to complete medical device development lifecycle.
- Strong understanding of medical device process design and regulatory processes.
- Good collaboration, active listening & excellent written and verbal communication.
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