If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Human Factors Engineer in Gaithersburg, MD you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
The Human Factors Engineer will be responsible for the Human Factors / Usability Engineering efforts on product development programs at the company. Key responsibilities will include design and execution of formative and summative studies for combination products in addition to managing outside vendors working to execute formative and summative studies.
Executes usability related processes, and trains others in their use. Performs use error risk analysis and integrates analysis into risk management and product design. Leads and provides support in product development activities including developing user needs and requirements documentation. Leads and assists in the development of instructions for use for combination products. Designs and conducts formative and summative usability studies, including protocol development and writing study reports. Manages relationships with outside vendors contracted to assist in the design and execution of formative and summative usability studies. Continually updates human factors / usability engineering report. Incorporates findings from usability studies into risk analyses and translates findings into actionable design changes to improve the usability of the product. Plans and conducts market research to identify and prioritize usability improvement possibilities.
Education: BS / BA degree in a relevant field with at least 3 years of experience. A degree in Human Factors / Usability or related discipline with a minimum of 2 years of experience in a medical device development or other regulated environment preferred.
Expertise in Human Factors / Usability Engineering and cognitive psychology. Experience applying Human Factors / Usability Engineering including design and execution of formative and summative studies applied to the design and development of medical devices and/or combination products in a regulated environment. In-depth knowledge and applications of AAMI, IEC, and U.S. Food and Drug Administration (FDA) regulations as they pertain to Human Factors and Usability. Excellent communication skills in both oral and written formats, as well as excellent listening and problem-solving skills. The ability to interface effectively with all levels and functions within the organization.
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.