Principal Engineer, Human Factors

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 innovate across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact health for humanity.

About the role

The Principal Engineer, Human Factors will work within the Human Factors & User Experience team in the Drug Delivery Systems (DDS) group as part of the broader Drug Product Development & Delivery (DPD&D) organization. This role contributes to Human Factors efforts across a broad range of combination product and drug product development programs, including subcutaneous and intramuscular injectors, nasal sprays, custom drug delivery devices, and complex drug preparation and administration procedures. The position supports Human Factors and Usability Engineering activities across various stages of development within the DDS group.

Responsibilities

• Work in a highly dynamic environment while supporting multiple projects simultaneously.
• Author, review, and contribute to Human Factors and engineering documentation, including study protocols, reports, manuscripts, design control documentation, regulatory submissions, and other technical documents; summarize, interpret, and communicate study results and conclusions.
• Apply advanced engineering and Human Factors methodologies to product development activities, maintain ownership of device specifications, and support product development and regulatory activities.
• Independently lead assigned projects; develop and implement new ideas and process improvements; manage priorities and timelines; and contribute to achievement of project objectives.
• Apply scientific and technical expertise to assigned projects; evaluate emerging technologies, methods, and literature; and identify opportunities to improve product quality, process efficiency, and technical approaches.
• Conduct literature reviews, stay current with scientific and technical developments, and apply relevant knowledge to ongoing and future projects.
• Participate in scientific meetings, professional development activities, and presentations to internal and external stakeholders, as appropriate.
• Establish project priorities, timelines, resource needs, and execution plans to support team objectives and deliverables.
• Manage project resources and budgets, ensure availability of required materials and equipment, support purchasing decisions, and identify cost-saving opportunities.
• Analyze and interpret data, make technical recommendations and decisions, refine methodologies, support regulatory inspection readiness, ensure compliance with applicable regulatory and quality requirements, and advise project teams on research objectives and resource utilization.
• Conduct user research and inquiries, facilitate user studies, gather and analyze data, identify user needs, develop user descriptions, and support regulatory interactions.

Requirements

• Bachelor’s degree in Human Factors, Usability Engineering, Industrial Design, Biomedical Engineering, or a related field, with a minimum of 8 years of relevant experience required; 6 years with a Master’s degree; or 4 years with a PhD.
• Experience applying Human Factors and Usability Engineering principles to the design and development of medical devices and/or combination products, including planning, conducting, and documenting formative and summative studies.
• Effective oral and written communication with strong interpersonal skills.
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.).

Preferred Qualifications

• Familiarity with applicable HF regulations and with ISO, FDA, International regulations, and ASTM standards.
• Experience with other aspects of drug and combination product development, including regulatory submissions for clinical trials and marketing approvals.

Skills

• 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

Pay

The anticipated base pay range for this position is $117,000.00 - $201,250.00. For Bay Area locations, the range is $134,000.00 - $231,150.00.

Benefits

• Retirement plan (pension) and savings plan (401(k)).
• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents).
• Holiday pay, including Floating Holidays – 13 days per calendar year.
• Work, Personal and Family Time – up to 40 hours per calendar year.
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.
• Caregiver Leave – 80 hours in a 52-week rolling period.
• Volunteer Leave – 32 hours per calendar year.
• Military Spouse Time-Off – 80 hours per calendar year.