Senior Human Factors Engineer, Electrophysiology

Johnson & Johnson•Irvine, CA

3d•$92,000 - $148,350•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/medtech We are searching for the best talent for a Senior Human Factors Engineer to support our Electrophysiology business. This role will work a Flex/Hybrid schedule with 3 days per week(could be more based on study support) onsite in our Irvine, CA office . Purpose: The Biosense Webster Usability and Design team is seeking a multi-faceted, exceptionally talented, user-centered Senior Human Factors Engineer who is passionate about improving the quality of people's lives through compelling design experiences. The Senior Human Factors Engineer will be responsible for providing human factors engineering expertise to multiple teams across the BWI portfolio, taking into consideration all aspects of the user experience. This will include early stage UX research and VOC analysis, User Performance evaluations e.g. EMG studies, formative and summative studies. The Senior Human Factors Engineer has strong experience in human factors engineering for medical devices. They will collaborate with cross-functional teams including R&D, Marketing, Project Management, Clinical & Medical Affairs and Quality. They will be responsible for educating and guiding teams through human factors activities and requirements throughout the product development process to ensure devices are safe, effective and easy to use.

Requirements

University/Bachelor's Degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology or Equivalent.
Minimum of 3 years work experience in human factors/usability engineering.
Hands-on involvement in FDA submissions (PMA, 510(k)) and EU MDR compliance.
The candidate has demonstrated ability to lead project-level human factors activities, including contextual inquiry, ethnographic studies, requirements definition, use-related risk analysis, formative usability assessments, and summative evaluation studies.
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
Fluent in English.
Ability to travel up to 20%, domestic and international is required.

Nice To Haves

Clinical experience and/or professional experience/degrees in design development and/or product development is a strong plus.
Industrial or Product Design experience.
Exposure to UX design principles and collaboration with design teams.
Good knowledge of the ISO 14971 and IEC 62304 are a plus
Experience with data analysis and programming tools e.g. MATLAB, python, r.
Experience in running and analyzing data from physiological studies e.g. EMG, blood oxygenation, etc.

Responsibilities

Influences 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.
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.
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.
Mentor other engineers on project and supervises/directs third party contractors/consultants; including reviews of deliverables to ensure accuracy.
Network 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.
Identify areas for innovation in human factors and design.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits