Principal Human Factors Engineer, remote

Insights & Human Factors Blue Ash, Ohio


The department uncovers, defines, and addresses user and stakeholder needs through to concept generation, design, development, verification, and validation. The products that we develop range from next generation combination drug injection devices and novel point-of-care diagnostic devices to revolutionizing acute care and surgical tools and digital health products in the life sciences. While a large portion of our business is in medical technologies, we have a robust consumer and industrial product portfolio, allowing us to cross-pollinate between industries and apply best-in-class methodologies from one to the other.

Your project work will include providing strategic guidance in starting and overseeing HF programs alongside your peers in design research, design, engineering, and project management. You will also be a trusted consultant to our clients as they navigate challenging product development roadmaps, offering advice and project plans that allow them to avoid pitfalls and reach clinical or commercial success. You will also use your invaluable knowledge to work collaboratively with business development teams and other senior members of the company. This may include identifying opportunities, participating in prospective client meetings, preparing sales materials, and writing up proposals.

At Kaleidoscope Innovation, we recognize and celebrate individual talent and we understand the importance of letting individuals be just that. Our people are here to do the best work of their lives and our job is to provide the platform for them to do it. That means letting people pursue the projects that interest them and develop their career in whatever direction they choose.

PRINCIPAL DUTIES & RESPONSIBILITIES
• Apply your knowledge of human performance and human factors techniques to the ideation, design, and development of physical and digital products.
• Guide, advise, and direct client teams as appropriate on human factors strategy as it relates to the product engineering, design, regulatory, quality, and business stakeholder priorities.
• Author usability plans and protocols set up and execute usability research and studies and create necessary reports and summaries for these studies. This individual may oversee the studies planned by other members of the team and provide direction to strategic process and research initiatives.
• Utilize excellent communication and presentation skills on projects. Leveraging experience in clinical environment is a plus.
• Author, review and edit engineering documentation related to assigned projects. This includes technical protocols, reports, and design control documentation.
• Evaluate and provide guidance on prototypes to support evolving hardware and software application development.
• Design and execute Human Factors studies to iteratively evaluating product user interface – including hardware, software, packaging, instructional material, and training.
• Train cross functional members on usability concepts and processes in order to leverage the team and collaborate with both internal and external stakeholders.
• Apply advanced engineering methodologies to product development activities.
• Collaborate with cross functional team members from mechanical, software, clinical, regulatory, and quality engineering disciplines.
• Perform use-safety engineering through Use-related Risk Analysis.
• Support internal and external quality audits.
• Implement Human Factors strategy in compliance with regional regulatory guidance and User Research strategy in compliance with Quality Management System Maintain ownership of device specifications and participate in drafting pertinent sections of Regulatory Filings as directed.
• Develop Human Factors Summary Reports in compliance with FDA guidance and Usability Engineering Files in compliance with IEC and ISO standards.
• Plan and conduct formative and summative usability testing and design validation that is compliant with IEC 62366 and FDA guidelines.
• Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advise management regarding potential improvements to internal processes and regulatory issues related to human factors engineering.
• Summary of main responsibilities but not exhaustive list.
QUALIFICATIONS
• Bachelor of Science (or higher) in Human Factors, Experimental Psychology, Cognitive Psychology, Cognitive Science, Industrial Design, Human-Computer Interaction or related fields
• 15+ years of professional Human Factors experience
• 6+ years in medical device development
• Experience with all phases of the product development life cycle including feasibility, planning, requirements, design and development, verification and validation, design freeze and phase gates, and design transfer strongly preferred
• You will need a solid understanding of the theories, principles, and data associated with human performance capabilities and limitations (perceptual, cognitive, motor, bio-mechanical, and anthropometric) and the ability to apply this knowledge to the design and definition of projects
• The Human Factors Engineer must be self-motivated and be able to work in a highly dynamic work environment with ability to serve multiple projects at the same time
• Moderate understanding of FDA Quality System Regulation, ISO 13485, ISO 14971, Medical Device Regulations (MDR), IEC 62304 and IEC 62366 requirements
• Experience with Human Factors/Usability in medical devices and familiarity with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance
• Expertise in user-facing activities and interacting with clinicians, preferred
• Utilize excellent communication and presentation skills in all settings to include executive level feedback, teammates, clients and peers within the product development process.
EEO/M/F/Disabled/Vet