Job Description

Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. General Summary Leads and supports human factors engineering design, development, and testing activities in cross-functional program teams innovating and improving medical device and consumer healthcare products. Primary Responsibilities Provides human factors support across all product development phases , including translating user requirements into design recommendations, reviewing hardware and software design concepts, conducting user interface design assessments, performing human factors testing and completing related reporting and analysis. Leads usability testing and human factors evaluations , including both formative and summative studies. Leads human factors engineering deliverables and develops customer-facing reports , including human interface analyses, cognitive walkthroughs, heuristic evaluations, and ergonomic and kinematic assessments. Applies human factors engineering expertise within cross-functional teams to evaluate the design space of consumer healthcare products and medical devices in accordance with regulatory standards. Ensures compliance with regulatory and industry standards such as FDA Human Factors Guidance (for medical devices) and ISO 9241 (for usability). Specific Responsibilities Develop and conduct human factors research studies independently or in conjunction with clients and/or government agencies. Plan and conduct user evaluations of product concepts, data analysis, document evaluation methods/results in detailed reports. Presents design recommendations to the project team. Manages and plans human factors activities to support product development programs Assist with analytical use risk analysis to predict and/or assess use error risk potential. Identifies design mitigations. Creates and communicates deliverables and manages time to meet deadlines. Guides clients through the human factors process. Trains and mentors new and less experienced human factors engineers. Provides leadership, training, guidance, and support to other engineers. May provide constructive feedback on performance of peers to functional management. Leads client interaction when necessary. Knowledge, Skills and Abilities Strong understanding of the principles of medical device and healthcare regulations Excellent written and oral communication skills Excellent attention to detail Ability to communicate visually via sketches, charts, and digital presentations Ability to multi-task and perform a wide range of activities Ability to work under a timeline Ability to solve moderate to complex technical problems Strong ability to effectively manage multiple tasks and projects Complexity A seasoned professional with full understanding of area of specialization. Resolves a wide range of issues in creative ways. Fully qualified level of the role. Problem Solving Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in area of expertise. Supervision Works independently; receives minimal guidance on day-to-day work and new projects or assignments. Typical Minimum Education Requirement* Bachelor’s degree in human factors engineering or related discipline Typical Minimum Experience Requirement* 3-6 year of relevant experience Physical Requirements Work is typically performed in an office environment, using basic muscular movements, involving only the handling of light materials, tools, or equipment in easy work positions, and with no special speed requirements or long stretches of exertion. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics. #J-18808-Ljbffr WORRELL DESIGN INC.

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