Preferred Qualifications - 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
Travel - Light-Moderate, up to 25% of the time
EEO/M/F/Disabled/Vet |
