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Role: Human Factors Engineer

Location: Burlington, MA

Duration: 12 Months on W2
Main Responsibilities

• 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 a 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.

Preferred Qualification

• Advanced degree in human factors engineering, biomedical engineering, or systems engineering.
• Experience working in a broader enterprise/cross-division business unit model