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Human Factors Engineer
HonorVet Technologies
🇺🇸 United States
Remote
Senior
3 days ago
$75.00 – $79.30 / hour
- IEC
3 days ago
Not enough detail in this posting to match
Job Title: Human Factors Engineer
Job Location: Remote
Job Duration: 06 Months
Position Overview :
- The *** Human Factors team is looking for an enthusiastic and team-focused Senior Human Factors Engineer that has a desire to apply Human Factors principles to design safe, effective and usable products for the diabetes-care industry.
- We have an exciting opportunity for an exceptional Senior Human Factors Engineer to apply his/her human factors expertise to the definition, design, evaluation, and validation of next-generation medical devices and systems. We are seeking an individual with proven Human Factors leadership and skills in the regulated environment of medical device product development.
- You will be joining a small, dynamic team of human factors engineers to contribute to the design and development of innovative, next-generation medical devices. The ideal candidate should be someone who is highly experience d with deep domain knowledge in Human Factors, thrives in highly collaborative environments, is an analytical thinker, has a high level of curiosity for problem solving, and wants to make a direct impact on patient lives by ensuring the products they use achieve world-class safety and usability.
- This position is remote within the United States.
Responsibilities:
- Author, review, and edit Human Factors engineering documentation related to assigned projects. This includes research protocols, research reports, Usability Engineering plans, Use-Related Risk Analyses, and other design control documentation.
- Support continuous improvement initiatives to strengthen Human Factors practices and documentation.
- Work cross functionally with the core team to ensure use-related risks have been comprehensively evaluated and that appropriate risk controls are in place to ensure safe and effective use.
- Ensure ***'s Human Factors Engineering process is in compliance with FDA recognized guidance and standards including IEC- 62366, HE75, and others.
- Provide research and design inputs related to human capabilities and product interactions to inform design and contribute to the verification and the validation of medical devices.
- Create and conduct formative and summative studies to support medical device design optimization and identify potential use errors.
- Analyze results from formative evaluations and make recommendations for improvements based on Human Factors guidelines and best practices .
- Participate in the development of product requirements and evaluation of risks related to product use (risk analysis)
Education and Experience:
- Bachelor's Degree in Human Factors , Human Computer Interaction, Cognitive Science, Biomedical Engineering, or related discipline
- Master's or Ph.D degree preferred
- 5 + years of work experience including 3 or more years of relevant Human Factors engineering experience in the medical device industry
- Ability to self-motivate and self-manage.
- Excellent verbal and written technical communication skills.
- Ability to plan and conduct effective meetings and presentations.
- Ability to collaborate effectively in multi-disciplinary teams.
- Willingness to travel as needed ( up to 25% of the time).
Skills/Competencies:
- Deep expertise in effectively and efficiently documenting Human Factors Engineering deliverables in the medical devices industry
- Demonstrated experience with use-related risk analyses on medical devices
- Background knowledge in diabetes and diabetes-care devices strongly preferred
- Deep understanding of FDA's Human Factors Guidance and recognized standards (HE75, IEC - 62366) related to medical devices, as well as theories, principles, and data associated with human performance capabilities and limitations
- Ability to apply Human Factors principles and methods to the design, definition, evaluation, launch, and use of medical devices
- Experience with user-centered design methods
- Experience with conducting formative and summative usability evaluations, including study moderation
- Ability to direct and mentor junior staff
Human Factors Engineer · HonorVet Technologies