Lead Human Factors Engineer

Johnson & Johnson MedTech is recruiting for a Lead Human Factors Engineer, to join the OTTAVA team. This location for this position is 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.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

In this critical role, you will contribute to the vision and delivery of the OTTAVA Robotic Surgical System. You'll lead Human Factors activities for this system and collaborate 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.

Our team is comprised of Human Factors Engineers, Industrial Designers, and UX Designers. Together, we help shape the user experience for OTTAVA, Johnson & Johnson's new surgical robotic system.

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.

Does the idea of working in medical robotics excite you? Are you a top technical leader who is motivated by impacting patients globally with your work? If so, we'd love to hear from you!

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.

Required Education:

• Bachelors Degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology, Biomedical Engineering or equivalent.

Experience and Skills:

Required

• Minimum 8+ years' work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions. (Note: Post-Graduate Degrees (MS, PhD) may be considered as part of the applicant's professional experience.)
• 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.

Preferred:

• 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.

The Company maintains highly competitive, performance-based compensation programs.

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

The anticipated base pay range for this position is $141,000.00 to $227,700.00.