Engineer 3 - Human Factors

Terumo BCT, Inc.•Denver, CO

2d•$109,800 - $137,200•Onsite

About The Position

Work requires originality and judgement in performing independent human factors research, analysis, and evaluation using standard human factors engineering (HFE) theories, principles, and data to facilitate user-centered product design and development. Performs work which requires a broad knowledge of engineering precedents in the specialty area and a good knowledge of principles and practices of related specialties. The Human Factors Engineer 3 will apply HFE to system user interface definition, design, and evaluation for new product development, as well as support sustaining and innovation projects. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, leadership opportunities, and company practices and policies.

Requirements

Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Minimum 4 years experience.
Demonstrated skills in engineering and technical leadership in the design and development of medical devices.
Requires working knowledge of human factors, design controls, quality, and risk management regulations, standards, and guidances for medical devices.
Requires strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior.
Provides support for subordinates, junior engineers, technicians, and management.
Ability to influence without authority to drive user-centered design across functional partners.
Ability to moderate usability studies in a manner that produces reliable data with minimal bias.
Ability to be innovative in approaches to accomplishing user-centered design and design for usability.
Strong technical writing skills to produce human factors protocols and reports for regulatory requirements and submissions.
Strong critical-thinking and problem-solving skills in diagnosing root causes of human factors issues and recommend user-centered design solutions.
Highly organized and able to work efficiently across multiple projects in parallel.
Demonstrated ability to communicate and present data and results effectively verbally, in writing, and through presentations to both technical and non-technical audiences.
Knowledge and use of relevant PC software applications and skills to use them effectively.
An equivalent competency level acquired through a variation of these qualifications may be considered.
General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
Requires domestic and international travel based on business needs.

Nice To Haves

Bachelor of Science Degree in Usability/Human Factors Engineering, Biomedical Engineering, Systems Engineering or related research-based degree, preferred.
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, preferred.
Experience with risk management activities for medical devices, specifically those applied by Human Factors (i.e. URA, UFMEA, AFMEA, UEA techniques), preferred.

Responsibilities

Leads the strategy, planning, and execution of human factors engineering activities and HF validation for new product development projects of all sizes and sustaining projects with impacts to the user interface.
Advises, reviews, and approves HF impact assessments for product design changes.
Conducts user-centered research including interviews, contextual inquiries, task analyses, and anthropomorphic evaluations for development of user and environment profiles, use specification, use cases, and usability/user interface requirements.
Exercises independent judgment in usability testing methodology, data collection, data analysis, conclusions, and design recommendations at various stages of product development from early prototypes through formal validation testing.
Ensures that product development projects are following HFE process compliant with all Company policies and procedures as well as existing IEC Usability standards, AAMI Human Factors standards and/or FDA and NMPA Human Factors Guidances.
Analyzes field data and reviews literature and publications to identify existing usability issues with on-market products.
Works with cross-functional teams to create and maintain use-related risk analyses and user interface requirements.
Actively collaborates in prototype development of user interfaces, including software, graphical user-interface, hardware or disposable components, and labeling and training.
Supports the development of internal tools for human factors data capture, analysis, and testing.
Contributes to identifying and developing design and development process improvements and best practices.
Reinforces customer empathy and human-centered design approach across the organization.
Keeps abreast of regulations and best practices for medical device human factors engineering (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices).
Responsibilities may include providing work direction to technicians and junior engineers.
Collaborate with other functional groups, technical disciplines, and levels of management including other engineering disciplines such as Systems and Software Systems, UX Designers, Product Technology Leads, Marketing, Regulatory, Project Managers, Global Services, and Global Product Support and Training.