R&D Human Factors Engineer # JN -042021-63406
Title : R&D Human Factors Engineer
Location : Burlington, MA
Duration : 06 months contract
- Owns pre-defined tasks within a large program, such as use case specification, use FMEA, and usability studies, and drives them to on-time high quality completion.
- Investigates and defines usability requirements for new product development
- Gathers and analyzes use errors and issues for medical devices and translates these into specific system risk mitigations.
- Simulates or tests aspects of new projects to evaluate prototypes and optimizes the user experience. Works with field and medical personnel to define the user experience of products/features.
- Applies advanced usability improvement principles to the evaluation and solution of complex product design problems.
- Creates detailed usability improvement concepts.
- Works across internal functions and geographic sites to create and manage usability deliverables.
- Remains abreast of and consults on usability improvement advancements.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Exercises independent judgment in the planning, organizing and performing work;
- Monitors performance and reports status to manager.
- Produces documentation, reports and analysis that adheres to FDA Guidelines for usability, as well as IEC Standards 62366 and 60601-1-6.
Experience and Required Education
- BS/BA Degree in human factors engineering, human computer interaction, human factors psychology, biomedical engineering, or systems engineering
- Minimum of 5 years of relevant work experience in medical product development and/or a graduate degree with relevant project experience.
- Demonstrated ability to apply understanding of human factors or usability engineering to issues in order to bring tasks to resolution within assigned projects.
- Demonstrated ability to effectively integrate information from varied disciplines including Engineering, Clinical Affairs, Marketing, and Regulatory Affairs.
- Medical device experience
- Strong analytical, problem solving skills
- Ability to work in a geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communication ability
- Meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 10% (following lifting of Covid restrictions)
- Ability to maintain regular and predictable attendance.
- Advanced degree in human factors engineering, biomedical engineering, or systems engineering.
- Experience working in a broader enterprise/cross-division business unit model