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Lieu: South San Francisco, Californie, États-Unis
ID de l'offre 10451971
Date de publication: 04/17/2019

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 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.

Position Summary:

This successful candidate will be able to lead human factors engineering work on a cross functional team developing drug delivery devices. 

Major Duties and Responsibilities (including supervising others):

The candidate will be responsible for the following activities:

  • Lead Human Factors efforts for combination product programs in development including ethnography, requirements definition research, formative studies, instruction and training development, risk analysis and summative 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, mechanical engineering, bioengineering or related discipline

  • MS and a minimum of 13 years of related experience or a PhD and a minimum of 7 years of related experience

Experience:

The successful candidate will have 7+ years of experience in combination product or medical device development experience. In addition, the successful candidate will have at least 5 years of HFE and/or combination product experience. They will have demonstrated the ability to support HFE activities including ethnographic research, requirements definition research, requirements writing, use-related risk analyses, formative usability assessments and/or final summative design validation studies. Experience evaluating instructions-for-use and training procedures is also a plus. The candidate should be capable of writing usability study protocols, performing statistical data analysis and writing study summary reports. They should also be familiar with US/EU guidance’s and standards related to human factors/usability, design controls and risk management.

Other Skills and Qualifications:

The position requires excellent oral and written communications skills and an ability to work with cross-functional teams including device development, regulatory, clinical, quality and program management.

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 lawAstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Human Factors Sr Engineer
MedImmune

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