We are raising the bar in the healthcare industry for our medical device, combination products, digital health and consumer-related products clients and are seeking an experienced and forward-thinking Principal Human Factors Engineer/Usability Engineer to join our dynamic product innovation team.
The successful Principal Human Factors Engineer / Usability Engineer (HFE/UE) will help guide and execute generative and industrial design research activities during early product feasibility, and the formative and summative studies under design controls and documentation through product submission. This person consider all aspects of the user population, intended and context of use by collaborating cross-functionally with both Kaleidoscope’s and our clients’ teams to create innovative, safe and intuitive-to-use products. The Principal HFE/UE will apply human-centered design best practices while maintaining adherence to user needs, and applicable guidelines, regulations and standards for the demonstration of safe and effective use.
This role will partner with the Director, Insights and Human Factors to assure client brand-driven aesthetics and user needs requirements are applied consistently through the planning, execution and reporting of pre-formative, formative and summative studies across assigned programs. The Principal HFE/UE will ensure expert input is provided to product teams for enforcing intuitive device design, packaging, product labeling and training materials, and supporting clinical studies, design verification and validation activities (where applicable).
Duties & Responsibilities
Contribute to and facilitate HFE/UE research, development and continuous improvement using HF/UE best practices in accordance with regulations and guidelines within the medical device, combination product and pharmaceutical industries.
Collaborates with internal and external partners and across internal functions (marketing, engineering, quality, design, etc.)
Implement human factors research to drive innovative and intuitive products
Support appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling and instructions for use while minimizing the potential for use errors.
Ensure human-system physical and cognitive capabilities and limitations and risk evaluations are properly reflected in the system, safety and user needs requirements.
Lead Kaleidoscope teams in determining and planning the need, types, priority, budgets and scheduling for Insights and/or Human Factors activities.
Mentor junior members of Insights & HF team.
Author, review, approve (where applicable) required documentation to plan, administer and execute all HFE/UE project activities.
Excellent communication, both verbally and in written format, plans, budgets, research strategies, activities and outcomes.
15 years of experience in the HFE/UE principles/methods of human-centered design, observational research, ergonomic design, human/machine interface, and data collection/reporting/analysis
Bachelor's degree in Human Factors, Human-Computer Interaction, Cognitive Psychology, and 10-15 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, strongly preferred
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 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, labeling and packaging
Working knowledge of design controls
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, ANSI/AAMI HE75:2009/ (R)2013, FDA Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Medical Devices
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 submission documentation (e.g. Usability engineering reports)
Experience in risk management, use-related risk assessment development
Participant recruiting, interviewing, moderating and note-taking skills
Proven experience working in multiple projects with high demand schedules
Experience in collaboration with and leading internal and external partners including graphic and visual designers, regulatory, safety, legal, quality, industrial designers, and software and hardware engineering personnel
Working knowledge of Microsoft Office, PowerPoint, Visio, Excel, Adobe Photoshop, Illustrator, InDesign
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, wearable devices) or devices for invasive and non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal), Class I, IIa, IIb and Class III
Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering, industrial and visual design disciplines
Light-Moderate, up to 25% of the time
We help our partners identify, design and build products and experiences that support, heal and otherwise empower people. Together, we dare to ask, “What if lives could be dramatically transformed with dramatically better solutions?”
We call this Purpose Driven Innovation™.