Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.
Biologics • Human therapeutics • Development of novel products
April 11
🇺🇸 United States – Remote
💵 $104.9k - $134.7k / year
⏰ Full Time
🟠 Senior
🔴 Lead
👷🏻♀️ Engineer
🦅 H1B Visa Sponsor
Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.
Biologics • Human therapeutics • Development of novel products
• The Human Factors Engineer (HFE) /Usability Engineer (UE) is responsible for supporting HFE/UE planning, research, development of Amgen drug delivery devices using HFE/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. • This person is expected to collaborate with internal and external partners and across functions with engineering, design, commercial, quality, and regulatory teams. • This person will support human factors research driving innovative, intuitive, and useful products. • The HFE will support project study design, HF/UE methodology, study moderation, data collection, root cause analysis to inform design and apply sound HFE/UE knowledge and experience to research, development, clinical studies, and product validation in support of regulatory submissions.
• High school diploma / GED and 8 years of Human Factors Engineering/Usability Engineering experience OR Associate’s degree and 6 years of Human Factors Engineering/Usability Engineering experience OR Bachelor’s degree and 2 years of Human Factors Engineering/Usability Engineering experience OR Master’s degree • Medical device, combination product, non-combination product including small and large molecule experience including functional knowledge of applicable guidance, regulations and standards • Experience in front-end feasibility phase, exploratory research, user needs translation, ideation concept evaluations, device user interface evaluations, iterative design process, requirements and specification development, risk assessments, and formative testing • Experience supporting or leading various HF methodologies such as planning, coordinating, conducting, analyzing and reporting ethnographic research, interviews, contextual inquiries, use scenarios, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, expert analysis, task analysis, hazard analysis, risk assessment, formative study and summative studies • Ability to communicate effectively with mechanical, electrical, software, clinical, regulatory, and quality engineering disciplines • The position requires good oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products
• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible
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