Sr. Human Factors Engineer

6267-Auris Health Inc. Legal Entity; Cincinnati (OH); On-site; USD 92,000 - 148,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Senior Human Factors Engineer to join the OTTAVA™ team in Cincinnati, OH. You will lead human factors activities for the OTTAVA Robotic Surgical System, guiding usability strategies from concept through post‑market support and collaborating across R&D, QA, and regulatory functions.

The role requires 5+ years in medical device HF engineering, expertise in IEC 62366 and ISO 14971, and travel up to 20% domestically and internationally.

Qualifications

• Bachelor’s degree or equivalent in Human Factors Engineering or related field.
• 5+ years in human factors/usability engineering for medical devices.
• Proven ability to negotiate with stakeholders and influence risk management docs.
• Experience with IEC 62366, ISO 14971, IEC 62304; regulatory submissions.
• English fluency; travel up to 20% domestically and internationally.

Responsibilities

• Support the development and execution of human factors and usability strategies from concept through post-market support.
• Collaborate with R&D, Marketing, Medical Safety, Regulatory Affairs, Clinical Engineering, and Quality Engineering to align user needs with technical development.
• Prepare usability engineering documents including risk assessments, task analyses, use specifications, and test reports.
• Mentor engineers and supervise third‑party contractors; review results.
• Advocate for the voice of the customer from a human factors perspective in new product development.

Skills

Human factors

Usability testing

Regulatory submissions

IEC 62366

ISO 14971

GUI development

Software development

Education

Bachelor's degree in Human Factors Engineering

Job description

Job Title

Senior Human Factors Engineer, open to join the OTTAVA™ team, located in Cincinnati, OH.

Company Overview

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

Job Function: R&D Product Development

Job Sub Function: Industrial Design & Human Factors

Job Category: Scientific/Technology

All Job Posting Locations: Cincinnati, Ohio, United States of America

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness.

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.

Responsibilities

• Support the development and execution of human factors and usability strategies from initial concept through post-market support, facilitate usability efforts across product lines and programs with general direction.
• Address sophisticated issues that affect the program team, contributing to projects that involve identifying and analyzing multiple factors, while applying attention to detail 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.
• Network with multi‑functional team beyond own area of expertise, actively facilitate 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.

Education & Qualifications

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

Experience and Skills

Required Minimum 5 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. 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.

Required Skills

No separate skills list provided.

Preferred Skills

• Analytical Reasoning
• Concept Testing
• Critical Thinking
• Customer Intelligence
• Human Factor Engineering
• Product Design
• Product Improvements
• Report Writing
• Technical Credibility
• Technologically Savvy
• User Research

Salary

The anticipated base pay range for this position is : $92,000.00 - $148,350.00

Equal Opportunity

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Company Mission

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.