Job Description
JOB SUMMARY
Performs duties that require application of intensive and diversified knowledge of human factors engineering (HFE) theories, principles, and data to drive user-centered product design and development. Practices in broad areas of assignments and related fields. Develops and evaluates plans and criteria for a variety of projects and activities. Carries out complex or novel research assignments requiring the development of new or improved human factors engineering techniques and procedures.
ESSENTIAL DUTIES
Leads and is accountable for all human factors activities for multiple product development projects of all sizes and drives results.
Directs and drives user-centered research and design, utilizing engineering skills and experience to tackle or devise entirely new approaches to problems encountered in projects.
Guides the successful completion of major programs and may function in a project leadership role. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
Utilizes expertise in HFE to develop new processes or strategies that have a significant impact on multiple disciplines.
Contributes to the establishment of business objectives, goals, budgets and costs as requested.
Mentors less experienced engineers.
Provides broad-based direction for subordinates and colleagues within functional area and cross functionally.
Applies technical expertise to complex tasks with in-depth knowledge of related work areas.
Employs in-depth knowledge of cross functional and related technical areas, applying knowledge to other areas.
Displays accessibility and is sought out for consultation on complex human factors issues by engineering staff and management.
Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Keeps updated on recent technical advances, best practices, and regulations in human factors engineering and applies this knowledge to products and processes.
OTHER DUTIES AND RESPONSIBILITIES
Work direction responsibility may include technicians and junior engineers.
Collaborate with other functional groups, technical disciplines, and levels of management including other engineering disciplines, UX Designers, Technical Product Leads, Marketing, Regulatory, Project Managers, and Global Product Support and Training.
May contribute to the establishment of business objectives, goals, budgets and costs.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Bachelor’s of Science degree or Master of Science degree in Usability/Human Factors Engineering, Biomedical Engineering, Systems Engineering or related engineering or research-based degree preferred.
Experience
Minimum 8 years experience.
Experience with Human Factors/Usability in medical devices and with existing IEC Usability standards, AAMI Human Factors standards and/or FDA Human Factors Guidance.
Experience with risk management activities for medical devices, specifically those applied by Human Factors (i.e. URA, UFMEA, AFMEA, UEA techniques).
Skills
Requires demonstrated skills in technical innovation and technical leadership in the design and development of medical devices.
Proven experience in HFE principles and user-centered design (heuristic evaluations, user research, usability testing, and data collection/analysis methodologies).
Demonstrated interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team members, team behavior, and support for subordinates, junior engineers, technicians, and management.
Represents the organization as a prime technical contact on projects. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.
Ability to draw conclusions and make design recommendations based on technical inputs from multiple sources.
Ability to collaborate, be flexible, and creative in approach to solving human factors challenges.
Ability to develop technical specification requirements and provide significant input on technical procedures on various processes that impact multiple disciplines.
Knowledge and ability to implement HFE standards and guidances.
Driver for acquiring resources and building consensus across products.
Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
Demonstrated ability to communicate effectively both verbally and in writing.
Knowledge and use of relevant PC software applications and skills to use them effectively.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
PHYSICAL REQUIREMENTS
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.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Requires travel based on business needs.
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Job Tags
Flexible hours,