Human Factors Engineer/Usability Engineer Insights & Human Factors Cincinnati, Ohio Job Opportunity for Skilled and Forward-thinking Human Factors Engineer We are raising the bar in the healthcare industry for our medtech clients and are seeking a forward-thinking Human Factors Engineer/Usability Engineer to join our dynamic product innovation team. The successful Human Factors Engineer / Usability Engineer (HFE/UE) will help guide market research, human factors and industrial design research activities for development of Kaleidoscope clients medical devices/systems and consumer-related products. The HFE/UE will take into consideration all aspects of the intended user population, the context of use, intended use and the therapy, procedures and/or products being delivered by collaborating cross-functionally both with internal Kaleidoscope and external client team members that include quality, regulatory, safety, human factors, industrial and visual design, marketing, systems architecture and engineering, and manufacturing to create innovative and intuitive-to-use products through the application of human-centered design methodologies while maintaining adherence to applicable health authority guidelines, regulations and requirements for the demonstration of safe and effective use, risk mitigation, and user needs requirements. The Human Factors Engineer /Usability Engineer will work with the Director, Insights and Human Factors to assure client brand driven aesthetics are applied consistently, helping with planning, execution and reporting of human factors engineering, and user interface and industrial design studies across assigned programs according to current regulations and guidelines. The HFE/UE will ensure expert Insights and Human Factors input is provided to design teams for enforcing design, packaging, labeling and training requirements, and clinical studies, design verification and validation activities (where applicable) within the consumer industry, as well as physical and digital medical device industries, The HFE/UE Ensures: * Human-system capabilities and limitations are properly reflected in the system, safety risk and user needs requirements. * Assists Kaleidoscope internal and client external team members in determining and planning the need, types, priority, budgets and scheduling for Insights and/or Human Factors activities. The position requires the following: * Excellent organizational, technical problem solving and communication skills (verbally articulate with clearly written documentation), the ability to work in teams, the ability to adapt to a rapidly changing environment, and the ability to lead internal and external consultants. * Experience working directly with customers to gather, synthesize and convert user research into concepts that differentiate products in the market and produce consumers needs and preferences * Experience working directly with customers to develop and evaluate new product features, user interfaces and ergonomic designs, and with ensuring customer satisfaction * Proven experience in the HFE/UE principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/reporting/analysis * Proven experience with using sketch models, low and high-fidelity prototypes to identify and eliminate potential use errors early in the development process * Knowledge of relevant human factors regulations, standards and guidance for physical and digital medical devices and packaging * Good understanding of the principles of Medical Device and healthcare regulations including FDAs Quality System Regulation (QSR), ISO 13485, 14971, EN 60601, Council Directive 93/42/EEC, 62366. HE 75, AAMI. * Experience in experimental design of formative and summative human factor studies to address the needs of the requirements setting, design testing, verification and validation stages of physical and digital medical device development * Experience in authoring human factors engineering protocols and reports as support for registration documentation (e.g. Usability engineering reports) * Participant recruiting, Interviewing, moderating and note-taking skills * Proven experience working in multiple projects with high demand schedules * Experience in collaboration with external partners * Working knowledge of Microsoft Office, PowerPoint, Visio, Excel, Adobe Photoshop, Illustrator, InDesign * 25% yearly travel, and the ability to lift at least 25 pounds, package and transport and/or ship used research supplies and equipment, and lift and pack materials into cartons, cabinets at research facility locations, as well as within Kaleidoscope premises. Minimum Qualifications: * Masters degree & 1 - 2 years of applied HFE/UE engineering experience OR * Bachelors degree 2 to 3 years of applied HFE/UE engineering experience AND * 1 year of engineering experience collaborating with teams, projects, and programs Preferred Qualifications * Bachelor's degree in Human Factors, Human-Computer Interaction, Industrial Design, Cognitive Psychology, and 2 years of business experience, working in development organizations in multiple parallel and virtual development environments. * MS in Human Factors, Industrial Design, Cognitive Psychology. Other Engineering/Life Sciences related disciplines are a plus * Minimum of 1+ years experience working in the development of mechanical, electro-mechanical systems design, digital verification and validation * Demonstrated time management, decision making, presentation and organization skills * HFE/UE experience in the design and manufacturing scale-up of surgical tools, injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for invasive and non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal), Class IIa, IIb and Class III * Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering, industrial and visual design disciplines More About Kaleidoscope Innovation As a leading innovation and design consultancy, Kaleidoscope Innovation differentiates our work and the business partners we serve through the talents of the individuals who make up our team and share our vision for transformative, human-focused solutions. Founded in 1989 Kaleidoscope Innovation focuses on lasting partnerships with both employees and clients as we work together to uncover meaningful insights; originate new ideas; and develop products, services and experiences that empower business. We offer strategically developed deep subject matter expertise across key industries, positioning us to deliver unprecedented value. Our depth of knowledge provides a catalyst that generates new insights, ideas, products and services. Our team of talented strategists, researchers, designers and engineers combine their expertise with a shared passion to make the world a better place for our clients, their customers and consumers. Our team members help further the success of industry leaders, such as Procter & Gamble, Johnson & Johnson, Motorola, Ford, Smith & Nephew, Microsoft and Whirlpool. Kaleidoscope Innovation is headquartered in Greater Cincinnati?the home of the Bengals, the Reds, and FC Cincinnati Soccer, arts and entertainment, including its own symphony, pops orchestra, ballet and opera, and is a culinary hub featuring a range of cultural, traditional and progressive dining. From historical architecture and modern design to eclectic neighborhoods and year-round outdoor seasonal spaces, Cincinnati offers something for everyone right in the heart of the Midwest. Interested in joining our progressive team of forward-thinkers? Wed like to talk with you. EEO/M/F/Disabled/Vet