With the new guidance for Human Factors coming to China it is an exciting time for engineers looking to make medical devices more usable! Worrell is seeking a passionate and talented Human Factors Engineer for our Shanghai office who will be able to learn from our highly experienced US and UK teams.
We are looking for someone who is familiar with Human Factors and has awareness of the latest NMPA Guidance.
As a part of our Human Factors team you will work on a variety of projects to help identify usability issues, design usability engineering plans, participate in formative and summative usability studies, and prepare reports based on findings.
You will lead Human Factors studies for a variety of clients, with activities including: conducting usability studies with a range of Medical Professionals and Patients to understand user needs, identify use problems and root cause, and create detailed professional reports.
You will help the team interpret and understand user feedback to improve the safety and efficacy of the devices in development.
This is an opportunity to work with the largest global medical device manufacturers and pharmaceutical companies to truly impact the usability of medical devices as they are being designed and engineered.
- Manage and conduct a range of formative usability studies during concept development, and summative usability studies for human factors validation
- Participate in analytical use risk analysis to predict and/or assess use error risk potential and identify design mitigations
- Lead and create detailed HF protocols & reports
- Define user needs/requirements through gathering activities including ethnographic research, use case analysis, and/or task analysis
- Work with multidisciplinary teams, including the Human Factors team members in the UK and US.
- Degree in Industrial/Product Design, Biomedical or Mechanical Engineering, Ergonomics, Human Factors or Psychology
- At least 2 years’ experience in biomedical, mechanical, or human factors engineering with an emphasis on Medical Device products
- Experience in highly regulated industries such as healthcare (preferred), aerospace, aviation, etc. with an emphasis on quality assurance, design control, and risk management
- Understanding of current medical device Human Factors standards, NMPA guidance on HF and FDA Guidance (ie. ISO/IEC-62366-1, ANSI/HE-75, etc.)
- Excellent oral and written technical communication skills in both Mandarin and English (technical writing background is a plus)
- Encompasses a strong, self-motivated work ethic
- Ability to conduct one-on-one user interviews with utmost professionality, composure, and consistency
- Willingness to learn more about the future of Medical Devices
- Encompasses a positive attitude and good sense of humor (At Worrell, we take pride in our fun and unique culture!)
- Willing to travel to conduct usability studies