Sr. Human Factors Engineer

Brighter Signals; Cincinnati (OH); Presencial; USD 120 000 - 180 000; Tempo integral

Resumo da oferta

Johnson & Johnson MedTech seeks a Senior Human Factors Engineer to lead HF activities for the OTTAVA Robotic Surgical System in Cincinnati, OH. You will deliver sophisticated HF workstreams as a key contributor and mentor others, shaping usability across medical devices and collaborating with multiple departments.

The role requires 5+ years in HF/usability for medical devices, strong regulatory knowledge (IEC 62366, ISO 14971, IEC 62304) and the ability to travel up to 20%.

Qualificações

• Minimum 5 years’ work experience in human factors/usability engineering in Medical Devices.
• Proficiency with HF process including research, planning, risk assessment, user interface requirements, and regulatory submissions.
• Experience negotiating with stakeholders and providing feedback for risk management documentation.
• Expertise in planning, executing, documenting, and reporting usability studies.

Responsabilidades

• Support development and execution of human factors and usability strategies across product lines.
• Address sophisticated issues and analyze multiple factors using appropriate evaluation methods.
• Collaborate with R&D, Marketing, Regulatory, Clinical Eng., and Quality to align user needs with the development roadmap.
• Prepare precise usability documents: task analyses, risk assessments, test reports, and root cause analyses.
• Act as internal HF expert; improve HF processes to standards while tailoring to the business.
• Mentor engineers and supervise contractors; review results.
• Engage cross-functionally to advocate for the voice of the customer in new product development.

Conhecimentos

Human Factors Engineering

Usability Testing

Regulatory Submissions

Risk Assessment

User Interface Design

IEC 62366

ISO 14971 / IEC 62304

Stakeholder Negotiation

Mentoring / Leadership

Travel up to 20%

Formação académica

Bachelor’s Degree or equivalent in HFE/Usability/Related

Descrição da oferta de emprego

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. Learn more at jnj.com

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.

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

Job Description

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

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.

Learn more at https://www.jnj.com/medtech

Overview

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.

As a Senior Human Factors Engineer, you will be responsible for delivering on sophisticated HF workstreams as a key individual contributor while providing guidance and support across a range of HF activities. You'll bring experience and creativity that will help the team navigate interesting questions and challenges in the world of medical robotics. Our inclusive culture heavily emphasizes growth and development, and you'll take part in the continued advancement of HF practices and help uphold a high standard for the team.

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

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

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

Required Experience and Skills

• 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.

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