Global Principal Human Factors Engineer

Job Description

The Principal Human Factors Engineer will support the Executive Director of Global Human Factors as a Human Factors expert providing applicable training, mentoring and guidance in Human Factors and Usability Engineering processes across the Global organization; managing the creation and execution of Human Factors documentation to ensure compliance with regulatory requirements in alignment with the business strategy of the company. The ideal candidate is a hands-on project and multi-disciplinary technical leader with a strong medical device background and excellent communication skills.

Job Duties

• Provide project and technical leadership as it relates to Human Factors in the product development process including structuring and planning HF efforts, conducting HF activities and creating documentation.
• Establish and foster strong collaborative relationships with internal team members and external partners in the execution of HF activities.
• Provide expert consultation to multiple projects and multi-disciplinary design teams to execute HFE projects/studies and assume responsibility for project execution and quality.
• Serve as a key point of contact for HFE focused efforts.
• Develop and document HFE processes, tools, and templates for staff education and training.
• Author comprehensive human factors engineering protocols and reports (e.g., Usability engineering reports) and support the design and execution of formative and summative human factor studies to address the needs of the requirements setting, design testing, and validation stages of physical and digital medical devices.
• Ensure that expert HFE input is provided to product design teams and the Regulatory team for addressing design requirements, packaging requirements, IFU’s, design validation activities in support of regulatory submissions.
• Partner with Quality teams in ensuring appropriate risk assessment related to usability.
• Ensure that human capabilities and limitations are properly reflected in the system, safety risk and user needs requirements.
• Coach HFE team members through mentorship, training, and professional development.
• Maintain a deep understanding of all Global HF regulations including all FDA Guidance and IEC 62366.
• Partner with Marketing, Design, and R&D teams in engaging end users for user needs identification and user input to design concepts.

Job Qualifications

Required:

• Bachelor’s degree in Human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences related subject area is a minimum requirement.
• Minimum years of HF experience: 8 years with a M.S. or 12 years with a B.S. degree in Human Factors or other related discipline.
• Medical Device experience is required.
• It is preferred the candidate is certified as either: Certified Professional Ergonomist (CPE) or Certified Human Factors Professional (CHFP)
• Strong background developing and validating user requirements.
• Experience with complex, multi-functional development projects and cross-disciplinary teams.
• Proven experience on multiple projects with high-demand schedules.
• Demonstrated time management, decision making, presentation, and organization skills.
• Excellent organizational, technical problem solving, negotiation, and communication skills (written and verbal), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to manage external consultants.
• Proven experience in the Human Factors principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/analysis.
• Experience working directly with users to gather, synthesize and convert user research into robust set of user needs.
• Experience working directly with users to develop and evaluate new product features, user interfaces and ergonomic designs to track performance as it relates to usability goals.
• Thorough knowledge and expert understanding of the principles, standards and guidance for Human Factors in Medical Device and healthcare regulations including the FDA 2016 Guidance, ‘Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff’, the FDA 2022 Guidance, ‘Content of Human Factors Information in Medical Device Marketing Submissions Draft Guidance for Industry and Food and Drug Administration Staff’, Quality System Regulation (QSR), ISO 13485, 14971, EN 60601, Council Directive 93/42/EEC, 62366. HE 75, AAMI.
• Experience in the design of formative and summative human factor studies to address usability requirements, context of use, verification and validation stages of medical device development.
• Experience writing human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports).
• Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator.
• Will work with global teams, availability will include working across the associated time zones. International and domestic travel up to 15% of the time.

Preferred:

• Master's degree in Human Factors (HF), Cognitive Psychology, or other Engineering/Life Sciences related subject area is preferred.
• It is preferred the candidate is certified as either: Certified Professional Ergonomist (CPE) or Certified Human Factors Professional (CHFP).