Lead Human Factors Engineer

Johnson & Johnson Innovative Medicine•Santa Clara, CA

1d•Onsite

About The Position

Johnson & Johnson MedTech is seeking a Lead Human Factors Engineer to join the OTTAVA™ team in Santa Clara, CA. This role is critical to the vision and delivery of the OTTAVA™ Robotic Surgical System, focusing on developing next-generation, smarter, less invasive, and more personalized treatments. The successful candidate will lead Human Factors activities for the system, collaborating on breakthrough medical technologies that integrate multiple disciplines to bring J&J MedTech’s multi-quadrant surgical robotic system to global markets. As a Lead Human Factors Engineer, you will be responsible for managing sophisticated HF workstreams as a primary individual contributor, while also providing mentorship, review, and leadership across a broad range of HF workstreams. The position requires experience and creativity to navigate complex questions and challenges in medical robotics. The collaborative culture emphasizes growth and development, and you will contribute to mentoring and developing HF talent to maintain high team standards. This role is ideal for a top technical leader motivated by impacting patients globally through work in medical robotics.

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.

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.