- Master's Degree
- Bachelor's Degree
- Time Management
- FDA Regulations
- Communication Skills
- ISO 13485
Ximedica, LLC is a contract design, development and manufacturing company specializing in capital and disposable medical devices and instruments. Ximedica is an ISO 13485 certified and FDA registered firm with expertise in all aspects of product development, verification, design for and transition to production. Ximedica participates in the entire development process from initial design exploration to supply of finished goods. Its core competencies include mechanical and electronic design as well as firmware and software implementation. In addition, Ximedica offers design control, compliance-related documentation tracking and offshore sourcing of components and subassemblies.
We have a high-energy, collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours. We’re located in Providence, Rhode Island, a renaissance city with affordable lifestyle, great restaurants, pristine beaches, and a vibrant arts community.
Position: As a Human Factors Engineer you will report to the Director of Research and Strategy. In this role, you will lead human factors engineering activities in cross-functional program teams, and have the unique opportunity to work on a significantly diverse range of projects involving innovating and improving medical device and consumer healthcare products.
To be successful in this role, you will want to have hands-on experience conducting usability studies and in-person interviews, an expert understanding of the principles and data associated with human performance capabilities and limitations, and the ability to apply this knowledge to the design, definition and evaluation of consumer healthcare products and medical devices.
If you have an inquisitive mind, enjoy a fast-paced work environment, are not afraid of change, and possess superior verbal communication skills, please keep reading.
Provide human factors support across the product development lifecycle including client and user needs identification, user and workplace profile development, definition of target user capabilities and limitations, creation of use scenarios and task analyses, and conducting usability testing, use error analysis, and post-launch outcomes analysis
Plan and conduct end user evaluations of product concepts or prototypes, and document the results along with meaningful recommendations for the project team
Develop and conduct human factors research studies independently or in conjunction with clients
Act as both an internal and external thought leader representing Ximedica’s Human Factors Engineering program
A Bachelor’s or Master’s degree in Human Factors Engineering
Experience across a range of Human Factors research tools from usability studies to in-depth interviews
Strong organizational, time management and prioritizing skills
Exceptional attention to detail
Passion for the healthcare and/or medical device industry
Excellent written communication skills
Energetic, proactive self-starter
Ability to develop client presentations
Willingness and ability to flex between the big picture and small details, depending on the needs of the program
Working experience with the principles of medical device and healthcare regulations including the FDA Guidance on Human Factors, is a plus