Principal Engineer, Human Factors

Johnson & Johnson • Milpitas, PA

1d • Hybrid

About The Position

We are searching for the best talent for our Principal Engineer, Human Factors position, to be located in Malvern, PA or Milpitas, CA. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Purpose: 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. The Principal Engineer, Human Factors will work independently and under minimal supervision to contribute 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. This individual will support Human Factors and Usability Engineering activities across various stages of development within the DDS group. Responsibilities include authoring Human Factors plans and protocols, planning and executing Human Factors research and studies, and developing reports and summaries. Additional activities include conducting user research and inquiries, facilitating user studies, gathering and analyzing data, identifying user needs, developing user descriptions, and supporting regulatory interactions. You will be responsible for: Working in a highly dynamic environment while supporting multiple projects simultaneously. Authoring, reviewing, and contributing to Human Factors and engineering documentation, including study protocols, reports, manuscripts, design control documentation, regulatory submissions, and other technical documents; summarizing, interpreting, and communicating study results and conclusions. Applying advanced engineering and Human Factors methodologies to product development activities, maintaining ownership of device specifications, and supporting product development and regulatory activities. Independently leading assigned projects; developing and implementing new ideas and process improvements; managing priorities and timelines; and contributing to achievement of project objectives. Applying scientific and technical expertise to assigned projects; evaluating emerging technologies, methods, and literature; and identifying opportunities to improve product quality, process efficiency, and technical approaches. Conducting literature reviews, staying current with scientific and technical developments, and applying relevant knowledge to ongoing and future projects. Participating in scientific meetings, professional development activities, and presentations to internal and external stakeholders, as appropriate. Establishing project priorities, timelines, resource needs, and execution plans to support team objectives and deliverables. Managing project resources and budgets, ensuring availability of required materials and equipment, supporting purchasing decisions, and identifying cost-saving opportunities. Analyzing and interpreting data, making technical recommendations and decisions, refining methodologies, supporting regulatory inspection readiness, ensuring compliance with applicable regulatory and quality requirements, and advising project teams on research objectives and resource utilization.

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 required.
• Effective oral and written communication with strong interpersonal skills required.
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) is required.

Nice To Haves

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

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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal