Sr.Human Factors Engineer

Company Name:
Company Description:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Summary: Leads medical device design aspect, ergonomics and Human Factors development, including supporting user preference and human factor studies.
Job Description:
Lead Medical Device Human Factors Activities: Feasibility, device design development, ergonomics and design evaluation, etc.
Development of Instructions For Use, Manuals, package design and other usability and design related graphics
Project management activities with vendors, partners, and internal departments
Solidworks development and analysis of auto injector designs, provide suggestions, improvements and make ideas become design concepts
Statistical analysis of test results and study data
Experience and Required Skills:
Education and Experience:
Requires Bachelors in Science, Applied Science, Engineering, Industrial Design, Graphic Design or similar and 5+ year experience, Masters Degree with 3+ or PhD with 2+ years working with medical, commercial or industrial products from design, testing, validation, ergonomics and human factor perspective. Ideal candidate will have a combination of device design, testing, human factors and usability expertise in regulated environment.
Expertise with graphic design software like Adobe Suite is a must
Strong Technical writing and oral communication skills
Experience designing prototypes, evaluating ergonomics and human factors
Previous experience conducting formative and summative human factors studies is a plus
Experience writing technical documents like test reports, technical memos, input requirements documents, human factors protocols, etc.
Experience preparing information for 510(k),BLA, IDE, IP and PMA submissions, especially as relates to human factors, is a plus
Strong statistical skills is a plus
Working knowledge of Solidworks, MiniTab and Microsoft Project a strong plus
Lean, six-sigma, TQM system knowledge or experience a strong asset

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