User Experience Engineer I (1 of 2)

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As Ortho continues to grow, we are seeking a User Experience Engineer I. User Experience Engineers at this level are typically entry to mid-level professionals. This is an individual contributor role with opportunities for conducting user research, providing inputs to product design, evaluating use related risk, performing usability assessments to inform design, and contributing to the human factors validation of In Vitro Diagnostic devices and products. This position is located in Rochester, NY.

The Responsibilities

• Support early stage development with user research by conducting user interviews, site visits, contextual inquiries.
• Analyze findings to identify user needs, support design ease of use, and identify potential use errors.
• Perform workflow analysis and risk analysis activities such as task and use error analysis.
• Ensure traceability to design mitigations and requirements for critical tasks and risk areas.
• Responsible for supporting interface development, including wireframing, rapid prototyping, and evaluation of complex interface workflows via direct usability testing.
• Plan and execute Formative and Summative studies, write protocols, work with recruiter to coordinate participants and contracts, analyze data, document results, and present recommendations to product team.
• Prepare documentation to support development activities, design specifications, study protocols, use-related risk analysis, expert reviews, Human Factors Usability Engineering Files, Formative and Summative validation reports for inclusion in regulatory filing and subsequent post-marketing needs.
• Biohazard Lab environment work.
• May provide limited collaboration/oversight of more junior staff on initiatives and projects.
• Performs other work-related duties as assigned.

The Individual

• Bachelor's degree in Human factors or related discipline required.
• Advanced degree preferred.
• 1-3 years of UX/Human Factors applying user-centered design methodologies including generative research, user needs assessment, design concepts, and usability evaluations in support of product development.
• Confidence in conducting customer-facing activities.
• Strong written and verbal communication.
• Ability to work independently with minimal supervision.
• Collaborate easily with multi-functional development teams.
• Excellent attention to detail.
• Preferred experience applying Human Factors techniques and methodologies towards the design and development of medical devices in compliance with regulatory standards and guidelines. (e.g., FDA human Factors guidance, IEC 62366, AAMI HE75).
• Preferred experience with risk management activities (e.g., hazard analysis, UFMEA, URRA techniques).

Key Working Relationships:

Internal: Quality/Regulatory, Project Management, System Engineering, Product management, Lab Specialists, Software/ Hardware Engineers.

External: Customers, Development Partners.

EOE/AA Disability/Veteran

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