Lead Human Factors Engineer

Johnson & Johnson•Santa Clara, CA

16h•Onsite

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. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Johnson & Johnson MedTech is recruiting for a Lead Human Factors Engineer, to join the OTTAVA™ team in Santa Clara, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. This role contributes to the vision and delivery of the OTTAVA™ Robotic Surgical System, leading Human Factors activities for this system and collaborating on breakthrough medical technologies that unite multiple subject areas to help build and deliver J&J MedTech’s multi-quadrant surgical robotic system to markets, globally. As a Lead Human Factors Engineer, you will be responsible for running sophisticated HF workstreams as the primary individual contributor along with providing mentorship, review, and leadership across a broad range of HF workstreams. You'll bring experience and creativity that will help our team navigate interesting questions and challenges in the world of medical robotics. Our collaborative culture heavily emphasizes growth and development and you'll help mentor and develop HF talent to help continually set a high standard for the team.

Requirements

Bachelors Degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology, Biomedical Engineering or equivalent.
Minimum 8 years’ work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development for Medical Devices.
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.
Medical Device product development or experience working in a highly regulated industry.
Fluency in English, both written and verbal.
Willingness and ability to travel up to 20%, both domestically and internationally.

Nice To Haves

Clinical experience and/or professional experience/degrees in software development and/or GUI development is a strong plus.
Hands-on experience contributing to the development of both software and hardware solutions.
Analytical Reasoning
Coaching
Concept Testing
Critical Thinking
Customer Intelligence
Human Factor Engineering
Industry Analysis
Organizing
Product Design
Product Improvements
Product Portfolio Management
Product Strategies
Product Testing
Prototyping
Research and Development
Risk Management
SAP Product Lifecycle Management
Technical Credibility

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, ensuring a balance of the needs of users, surgeons, hospital staff, and patients in alignment with the technical development roadmap.
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.
Recognize the importance of alignment and negotiation to ensure seamless collaboration and successful outcomes.