Job Description
As our Human Factors Engineer, you will be working with a team to produce medical devices that are safe and effective for use by integrating the user experience into the design and development process. Your responsibility is to advocate for intended users and patient safety by minimizing the potential for use errors. In addition, you will participate in Design Validation and Usability studies by contributing to test plan development, development of test protocols, and help in the preparation of technical documentation for test reports. This is a hands-on role; outside of planning and documentation generation, you will be supporting formative and summative usability testing with end users and cadaver validation labs â" a confident, passionate, and easy-going personality is a must for this role in order to work with multiple cross-functional teams and to interface with end-users (i.e. surgeons).
Essential Responsibilities
- Strategize with project leaders to ensure human factors plans are appropriately scaled per medical device
- Review user needs and support user interface requirement development by utilizing anthropometry and biomechanics data
- Collaborate and contribute to tasks analysis, use risk analysis, user interface designs, and use specification development
- Contribute to or author User Interface Evaluation Plans, as well as formative and summative usability protocols
- Coordinate usability studies and design validation labs by gathering equipment and setting up labs
- Moderate and/or take notes for usability studies (may require minimal travel to remote test sites)
- Support usability engineering file and human factors engineering submission report
- Participate in ongoing process improvements and HFE related initiatives
Required Skills & Experience
- Typically requires a Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience
- Bachelor's or advanced degree in Biomedical, Electrical or Mechanical Engineering, or related technical discipline
- Understanding of medical device design, development, and risk processes (i.e., ISO 13485, 21 CFR 820, ISO 14971)
- Awareness of human factors requirements for both US (i.e., 2016 FDA Guidance for Human Factors) and International (i.e., IEC 62366-1 and 62366-2)
- Excellent problem recognition and problem solving skills
- Excellent interpersonal and communication skills
- Ability to work effectively within a cross functional team
Nice to Have Skills & Experience
- Previously held a Human Factors Engineer position
- Degree in Human Factors Engineering
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.