Principal Human Factors Engineer

The team provides Human Factors activities in all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue the company mission to save and sustain lives.

In this role as a Principal Human Factors Engineer, you will directly influence the usability and the patients/user's perception of the company products. In this role you will apply human factors engineering principles to the design, development, and evaluation of medical products while working with cross-functional program teams

What you will be doing:

• Lead human factors engineering work and research for medical devices and regulated healthcare products
• Performing human factors/usability studies (formative and summative) for hardware, software, labeling, and disposable products
• Design and execute usability evaluations to secure safe and easy product use
• Lead the development of a Use-Related Risk Analysis, as part of the risk file for the products
• Developing and communicating Human Factors project scope, plans, tasks and deliverables with program teams; managing time to meet project deadlines. This includes reporting pertinent information at key milestones through clear, concise oral and written communications
• In partnership with other R&D teams, developing product prototypes for user interface evaluation and validation
• With minimal direction, responsible for directing and coordinating all human factors activities necessary to complete a major product development program or several small projects
• Leading efforts to develop processes and procedures that align to company initiatives and FDA/international human factors standards
• Providing technical supervision to less experienced human factors engineers and may be responsible for the management of a small work group
• Presenting and advising on human factors topics across the organization

What you will bring:

• 5 years of human factors relevant experience; experience in medical device industry preferred
• Proven experience in HFE principles and methodologies (ergonomics, usability evaluations, data collection, data analysis, etc.).
• Proven experience in applying human factors techniques on programs across product lifecycle (user research, prototyping, formative & summative product evaluation, use-related risk analysis, etc.).
• Demonstrated working knowledge of IEC 60601-1-6, IEC 62366, and FDA HF/Usability Guidance Document and experience working in regulated industry
• Strong interpersonal and communication skills in written and verbal form
• Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc.).
• Demonstrated ability to provide technical leadership for HFE projects with substantial complexity and scope.
• Ability to decompose complex problems into actionable task lists Understanding of design requirements for development, validation, and verification of medical products
  

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com