Johnson & Johnson MedTech, Electrophysiology is looking for an experienced UXHF Manager to lead human factors engineering efforts for their product lines, ensuring user-centered design and usability throughout the product development lifecycle.
Requirements
- Minimum of 8 years' work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions is required.
- Demonstrated proficiency with the human factors engineering process, including research, planning, risk assessment, and regulatory submissions.
- Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk management documentation.
- Expertise in planning, executing, documenting, and reporting usability testing, including moderation of studies.
- Knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering
- Good knowledge of the ISO 14971 and IEC 62304.
- Medical Device product development or experience working in a highly regulated industry is a strong plus.
Responsibilities
- The UXHF manager creates the HF/Usability strategy and leads human factors efforts for programs from concept through post market support, supporting and influences usability activities for product lines and programs with minimal oversight.
- The UXHF manager will develop a good understanding of intended use environments gained through time spent in the field, and a good understanding of intended user types formed through interactions with users.
- The position requires work on problems of diverse scope that impact broader program team and business and leads projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for evaluations.
- The UCHF manager mentors other engineers on project and supervises/directs third party contractors/consultants; including reviews of deliverables to ensure accuracy. Holds team accountable for definition, design, and execution of HFE activities throughout product development.
- Has subject matter expert in a human factor and user design to complete human factor assessments. Ability to designs formative and summative studies to identify and reduce the potential for use errors and improve user experience.
- Responsible to work cross functional to support regulatory submissions and responses.
- Develops actionable insights for research and development (R&D), systems, and initiatives related to new technologies or therapies, from design to implementation, while adhering to policies, using in-depth knowledge and skills.
Other
- This role is a minimum of 80% onsite at our Irvine location.
- The position networks with key contacts outside own area of expertise, contributes to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development.
- Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within established timelines and budgets.
- Ability to travel up to 20%, domestic and international is required.
- Fluent in English.
