Job Function: R&D Product Development
Job Sub Function: Industrial Design & Human Factors
Job Category:Scientific/Technology
All Job Posting Locations:Malvern, Pennsylvania, United States of America
Job Description:An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for
Senior Engineer, Human Factors position.
The ideal candidate 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.
You will be responsible for:- 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.
Qualifications / Requirements:Education- Minimum of a bachelor's degree in human factors, usability engineering, industrial design, biomedical engineering, or related field is required. Master's, PhD or other advanced degrees are preferred.
Experience and SkillsRequired:- 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
- The successful candidate must have effective oral and written communication with strong interpersonal skills.
- Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.)
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
#LI- Hybrid
Required Skills: Preferred Skills:Analytical Reasoning, Coaching, Concept Testing, Critical Thinking, Customer Intelligence, Human Factor Engineering, Manufacturing Engineering, Market Savvy, Product Costing, Product Design, Product Improvements, Prototyping, Report Writing, Research and Development, SAP Product Lifecycle Management, Technical Credibility, Technologically Savvy, User Research
