Advisor, Human Factors Engineering

🕒 Yesterday

🇺🇸 United States – Remote

💵 $129k - $209k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥 Software Engineer

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Provide expert Human Factors Engineering guidance to cross-functional combination product development teams • Provide input into combination product and system requirements based on user needs and Human Factors Engineering expertise • Document user capabilities, limitations, and associated use-related risks in planning, requirements development, and design and engineering • Document user performance characteristics and associated benefits and risks to support design alternative decisions • Maintain compliance with IEC 62366, ANSI/AAMI HE75, and relevant FDA guidance • Plan and execute Human Factors Engineering activities with cross-functional teams • Lead user research studies, including contextual inquiry, diary, and observational studies • Develop and execute formative and summative usability studies • Conduct heuristic evaluations and expert reviews • Perform use-related risk analyses • Report and manage Human Factors evaluation findings • Author usability documentation for design history files and product development • Prepare Human Factors/Usability Engineering reports for regulatory submissions • Collaborate on product design language documents, style guides, design specifications, concepts, and prototypes • Build and maintain Industrial Design capabilities and help define team operating mechanisms and metrics • Align human factors strategy with business objectives and portfolio priorities • Assist with internal Human Factors Engineering staff training and process improvement • Maintain procedures and tools related to Human Factors Engineering best practices • Serve as an internal and external opinion leader, including publishing and public speaking • Conduct Human Factors Engineering workshops and seminars for multifunctional audiences

🎯 Requirements

• Earned Master's degree in Human Factors / Usability Engineering or a related field with 6+ years relevant experience • Extensive experience applying Human Factors Engineering to the development of medical devices or combination products • Experience in the design of usability study protocols and reports, including usability root cause analysis and risk benefit analysis • Experience working in a regulated environment • Excellent organizational, technical problem solving, and communication skills (written and verbal) • Strong interpersonal skills and team mind-set • In-depth technical knowledge of Human Factors Engineering methods and deliverables throughout the entire product development lifecycle • Familiarity with managing or participating in external consulting relationships to execute usability activities • Experience with software and/or electromechanical systems • Experience in risk management • Ability to identify systemic problems and drive strategic improvements • Experience using AI tools in technical or research work, with judgment about their reliability and the need for human expertise • Ability to travel domestically and internationally approximately 20–30%

🏖️ Benefits

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities