Senior Engineer, Human Factors

Johnson & JohnsonMalvern, PA
Hybrid

About The Position

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. This role will work independently under the guidance of management to contribute to the Human Factors efforts for a broad range of combination product and drug only development programs, including subcutaneous and intramuscular injectors, nasal sprays, custom drug delivery devices and complex drug preparation and administration procedures. They will work on assigned projects to provide support for the Human Factors / Usability Engineering activities in various stages of development within the Drug Delivery Systems [DDS] group in Johnson & Johnson Innovative Medicine. The individual will author Human Factors plans and protocols, set up and execute Human Factors research and studies and create necessary reports and summaries for these studies. Specific tasks include conducting user research/inquiries, user studies, data gathering, data analysis, identification of user needs and creation of detailed user description documents.

Requirements

  • Minimum of a bachelor's degree in human factors, usability engineering, industrial design, biomedical engineering, or related field is required.
  • 0-6 years of meaningful experience based on educational background and highest degree achieved
  • Experience must include applying Human Factors / Usability Engineering, including design and execution of formative and summative studies, to the design and development of medical devices/combination products
  • Effective oral and written communication with strong interpersonal skills.
  • Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.)

Nice To Haves

  • Master's, PhD or other advanced degrees are preferred.
  • 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

Responsibilities

  • Apply human-centered principles, methodologies, and technologies to achieve desired results from human-machine systems and products.
  • Execute qualitative and quantitative analysis plans with high-level guidance to test and evaluate new concepts and prototypes used in all phases of product development.
  • Author, review, and edit engineering documentation related to assigned projects. This includes technical protocols, reports, and design control documentation.
  • Maintain ownership of device specifications and participate in drafting pertinent sections of Regulatory Filings as directed.
  • Construct product testing and research to determine user needs, concept exploration/selection/refinement, product requirements, use-related risks, and formal usability validation with intended users.
  • Assess use-related problems or risks and directs implementation of corrective measures.
  • Establish protocol and activities for human factors investigations and implement research and analysis plans to facilitate the design direction of new product development.
  • Coach more junior colleagues in techniques, processes, and responsibilities. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Benefits

  • 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.
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