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Location:
San Francisco, California, United States
South San Francisco, California, United States
Job reference: R-047841
Posted date: Mar. 27, 2019
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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.  

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.

The successful candidate will provide human factors expertise and lead human factors engineering work ondevice development project teams developing drug delivery devices. The Human Factors Engineer will collaborate with these cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to guide development of combination drug device products and ensure these products are safe and effective for use.  

Major Duties and Responsibilities (including supervising others):

The candidate will be responsible for the following activities:

  • Developing human factors engineering strategies and leading HF activities on drug-device combination product program teams, including ethnography, requirements definition research, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies
  • Writing and reviewing HF sections for health authority submissions.
  • Interacting with health authorities during face to face meetings and in written responses.
  • Interacting with senior leaders with regards to HF strategy and implementation.
  • Improving internal Human Factors processes at MedImmune to ensure consistency, compliance and efficiency

Education

  • Degree in human factors engineering, bioengineering, mechanical engineering, , or related discipline

Experience:

  • The right candidate will have 3+ years’ experience in applying Human Factors engineering to medical device or combination product development. Years of required experience will vary based on the highest level of education completed, the level of expertise within combination products and the level of position being interviewed for.
  • Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidances for medical devices and combination products
  • Experience working cross-functionally on risk management activities
  • Proven ability to clearly communicate how study results can be implemented into design
  • Experience working with external consultancies, or as part of an external consultancy team that supported the design and development of new medical devices
  • Ability to analyze data, including knowledge and proficiency with basic statistics

Other Skills and Qualifications:

  • Ability to communicate effectively in writing, verbally, and as a presenter
  • Demonstrated tie management, decision making, presentation, and organization skills
  • Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
  • High level of initiative and ability to work independently

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

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Human Factors Engineer - (Scientist I/II) - BPD
MedImmune

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