Open Positions:

(Please note: All positions require team members to be located in Philadelphia or the UK. Our UK team is fully remote while Philadelphia is a hybrid team. All positions require some travel.)

Senior Human Factors Engineer

Position Overview: 

We are seeking a highly skilled and experienced Senior Human Factors Engineer to join our research consultancy. As a Senior Human Factors Engineer, you will play a key role in ensuring the usability, safety, and effectiveness of medical devices and consumer products through the application of human factors engineering principles and best practices. You will collaborate with clients to provide expert guidance and support throughout the product development lifecycle. The successful candidate will have a deep understanding of human factors engineering within the context of medical device design, along with exceptional communication, leadership, and project management skills. 

Responsibilities: 

• Human Factors Consulting: Provide expert human factors consulting services to clients in the medical device and consumer product industries, guiding them in the application of human factors engineering principles and regulations to optimize the usability and safety of their products.
• User Research: Design and conduct user research activities, including contextual inquiries, interviews, surveys and focus groups, to gain insights into user needs, preferences, and behaviors for medical devices and consumer products across various settings.
• Usability Testing: Design and conduct usability tests, including formative evaluations and summative validations. Identify and address usability issues early in the product development process. Provide actionable recommendations for product improvements based on test results.
• Risk Assessment and Mitigation: Conduct comprehensive risk assessments and hazard analyses related to human factors and use error for medical devices. Develop strategies and recommendations to mitigate identified risks and enhance the safety of the products.
• Usability Engineering File Development: Lead the development of usability engineering files, including task analyses, use-related risk analyses, and usability validation plans, in compliance with applicable regulatory standards (e.g., FDA, IEC 62366).
• Regulatory Compliance: Stay up-to-date with relevant regulations, guidelines, and standards pertaining to human factors engineering and usability in the medical device industry (e.g., FDA Human Factors Engineering Guidance, ISO 14971). Assist clients in achieving regulatory compliance.
• Client Collaboration: Build strong relationships with clients, working collaboratively to understand their needs, objectives, and constraints. Provide guidance and strategic recommendations for integrating human factors considerations into their product development processes.
• Leadership and Mentoring: Lead and mentor junior human factors specialists within the consultancy, providing guidance, support, and professional development opportunities.
• Industry Knowledge Sharing: Stay abreast of emerging trends, technologies, and advancements in human factors engineering and usability within the medical device and consumer product industries. Share knowledge and insights with colleagues and clients through presentations, workshops, and publications.

Qualifications: 

• Education: A bachelor’s or master’s degree in Human Factors Engineering, Industrial Design, Cognitive Psychology, Human-Computer Interaction, or a related field. Advanced certifications in Human Factors or Usability Engineering are highly desirable.
• Experience: Minimum of 7 years of professional experience in human factors engineering, usability engineering, or a related field, with a focus on medical device design and development. Experience within a consultancy or healthcare setting is preferred.
• Medical Device Expertise: Strong understanding of human factors engineering principles and methodologies as they apply to medical device design, usability, and safety. Familiarity with relevant standards and regulations, such as FDA’s Human Factors Engineering Guidance and IEC 62366, is essential.
• Usability Testing and Research: Proven experience in conducting user research studies, usability tests, and formative evaluations for medical devices. Proficiency in qualitative and quantitative research methods and data analysis techniques.
• Regulatory Knowledge: Deep understanding of medical device regulations and standards, including FDA requirements for human factors engineering and usability. Experience in preparing and supporting regulatory submissions related to human factors engineering is highly advantageous.
• Project Management: Excellent organizational and project management skills, with the ability to manage multiple projects simultaneously, meet deadlines, and deliver high-quality work within budgetary constraints.

To apply, please send your CV and a brief introduction to [email protected].

Human Factors Engineer  

Position Overview: 

We are seeking a motivated and talented Human Factors Engineer to join our team at Root Cause Insights (RCI). As a Human Factors Engineer, you will have the opportunity to work alongside experienced professionals in the field and contribute to the development of safe and user-friendly products. You will support the execution of human factors research activities, conduct user research, and assist in the implementation of usability testing and risk management processes. This position offers a unique learning and growth opportunity for individuals passionate about human factors engineering and product development within both the medical device and consumer product industry.  

Responsibilities: 

• Human Factors Support: Assist senior RCI team members in providing human factors engineering support to clients in the medical device and consumer product industry, contributing to the optimization of product usability and safety (when applicable).
• User Research Assistance: Participate in user research activities, such as conducting interviews, administering surveys, and observing user interactions, to gather insights into user needs, preferences, and behaviors related to product development.
• Usability Testing Support: Assist in the planning, preparation, and execution of formative and validation tests. Help collect and analyze data, and contribute to the identification and documentation of usability issues and improvement opportunities.
• Risk Assessment Assistance: Support the team in conducting risk assessments and hazard analyses related to human factors and use error for product development (particularly medical devices). Contribute to the development of strategies and recommendations to mitigate identified risks.
• Regulatory Compliance: Stay informed about relevant regulations, guidelines, and standards in the medical device industry, such as FDA Human Factors Engineering Guidance and IEC 62366. Support the team in ensuring compliance with applicable regulatory requirements.
• Documentation and Reporting: Assist in the development of usability engineering files, including task analyses, use-related risk analyses, and usability validation plans, ensuring accurate and comprehensive documentation in compliance with regulatory standards.
• Collaboration: Collaborate effectively with cross-functional teams, including human factors engineers, product designers, and clients, to integrate human factors considerations into the product development process. Contribute ideas and insights to improve the user experience.
• Learning and Development: Continuously expand your knowledge and skills in human factors engineering and usability through training opportunities, literature reviews, and active participation in professional development activities.
• Quality Assurance: Support the implementation of quality assurance processes, including the review of deliverables, adherence to standard operating procedures, and the maintenance of project documentation.

Qualifications: 

• Education: A bachelor’s or master’s degree in Human Factors Engineering, Industrial Design, Cognitive Psychology, Human-Computer Interaction, or a related field. Relevant coursework or internships in human factors engineering and usability are advantageous.
• Knowledge of Human Factors: Basic understanding of human factors engineering principles, methodologies, and best practices as they apply to medical device design and usability.
• Research Skills: Basic familiarity with user research methods, including qualitative and quantitative techniques. Ability to assist in data collection, analysis, and interpretation.
• Attention to Detail: Strong attention to detail to ensure accuracy and completeness of documentation and project deliverables.
• Communication: Excellent verbal and written communication skills, with the ability to effectively collaborate with team members and communicate findings and recommendations.
• Analytical Abilities: Basic analytical and problem-solving skills to contribute to the identification and resolution of usability issues and risk mitigation strategies.
• Regulatory Awareness: Familiarity with medical device regulations and standards, such as FDA requirements for human factors engineering and usability, is desirable.
• Software Proficiency: Proficiency in Microsoft Office suite (Word, Excel, PowerPoint) and data analysis software (e.g., SPSS, Excel) is preferred. Experience with usability testing tools and software is a plus.
• Adaptability: Ability to learn quickly, work in a dynamic and fast-paced environment, and adapt to changing project requirements.

To apply, please send your CV and a brief introduction to [email protected].

Research Analyst

Job Summary: 

We are seeking a motivated and detail-oriented Research Analyst to join our dynamic team at RCI. As a Research Analyst, you will assist in conducting research and analyzing your findings to support our client’s decision-making process. This entry-level position offers an excellent opportunity to gain hands-on experience in research methodologies and contribute to the success of RCI. 

Responsibilities: 

• Collect and analyze data on product use, competitors, and customer preferences using various research methods, such as surveys, interviews, and data analysis. 
• Assist in designing and executing research studies, including developing questionnaires, conducting interviews, and managing data collection. 
• Conduct literature reviews and secondary research to gather relevant industry insights and trends. 
• Assist in preparing research reports and presentations, summarizing findings, and providing actionable recommendations to stakeholders. 
• Collaborate with cross-functional teams to support research needs. 

Requirements: 

• Bachelor’s degree.
• Strong analytical and problem-solving skills, with the ability to interpret and synthesize data effectively. 
• Proficiency in MS Excel.
• Excellent verbal and written communication skills, with the ability to present findings in a clear and concise manner. 
• Detail-oriented mindset and ability to manage multiple tasks and deadlines simultaneously. 
• Basic knowledge of research methodologies and familiarity with survey design and data collection techniques is a plus. 
• Strong organizational skills and ability to work both independently and collaboratively in a team environment. 

This is an exciting opportunity for a motivated individual to kickstart their career in research and product development. As a Research Analyst, you will have the chance to contribute to meaningful projects, gain valuable experience, and grow professionally within RCI! 

To apply, please send your CV and a brief introduction to [email protected].

Don’t See Anything You Like?

We are always looking to add to our growing team at RCI! If you don’t see an open position that fits your background, please feel free to reach out to us to discuss additional opportunities.