Johnson & Johnson is looking to solve the problem of improving and expanding the possibilities of surgery by developing the next generation of smarter, less invasive, more personalized treatments, specifically through the OTTAVA Robotic Surgical System.
Requirements
- Minimum 8+ years’ work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions.
- Demonstrated proficiency with the human factors engineering process, including research, planning, risk assessment, user interface requirements, 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.
- Ability to own and/or support user workflow and user interface designs, including the negotiation of design recommendations to mitigate use errors and improve usability.
- Proven knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering.
- Solid understanding of ISO 14971 and IEC 62304.
Responsibilities
- Drive human factors and usability strategies from initial concept through post-market support, actively supporting and shaping usability efforts across product lines and programs with minimal direction.
- Tackle complex issues of varying scope that affect the wider program team and business, leading projects that involve identifying and analyzing multiple factors, while demonstrating sound judgment in choosing appropriate methods and techniques for evaluations.
- Collaborate with R&D, Marketing, Medical Safety, Regulatory Affairs, Clinical Engineering, and Quality Engineering to design, evaluate, and provide guidance on solutions and their user-related impact throughout the entire care process.
- Prepare precise and concise usability engineering documents for multiple projects in a timely manner, including task analyses, usability risk assessments, use specifications, test reports and root cause analyses, and usability engineering plans.
- Act as internal expert and advisor on human factors (including ergonomic and anthropometric principles) and continuously improve our HF process to align it with standards and guidances while also customizing it for the specific realities of our business.
- Mentor other engineers on project and supervise/direct third party contractors/consultants; including reviews of results to ensure accuracy.
- Network with multi-functional team beyond own area of expertise, actively contribute to multi-functional decision-making, and advocate for the voice of the customer from a human factors and technical application perspective in new product development.
Other
- Bachelors Degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology, Biomedical Engineering or equivalent.
- Willingness and ability to travel up to 20%, both domestically and internationally.
- Fluency in English, both written and verbal.
- Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year, Sick time - up to 40 hours per calendar year, Holiday pay, including Floating Holidays – up to 13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year
- Johnson & Johnson is an Equal Opportunity Employer.
