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Engineering Manager, Human Factors - Biopharmaceutical Development

Местоположение South San Francisco, Калифорния, США Идентификатор вакансии R-095261 Дата публикации 12/15/2020

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

About AstraZeneca in South San Fran:

In 2013, AstraZeneca acquired Pearl to expand and strengthen its respiratory products portfolio, We have made strides in bringing therapies to asthma patients. Our mission and vision are to develop differentiated therapeutics for widely prevalent respiratory disease conditions, including chronic obstructive pulmonary disease (COPD), by utilizing a proprietary drug delivery platform and existing therapeutic agents administered in metered-dose inhalers (MDIs). Join us as a Senior Human Factors Engineer at our South San Francisco site, which is located in the heart of the San Francisco Bay Area,  a perfect environment for employees who want to feel close to big city life yet avoid long commutes and congested streets.   It is the birthplace of biotechnology and located on a peninsula, with beautiful views of the bay, a vibrant working-class community, which includes numerous restaurants, parks and a marina.

The Bay Area has mild winters and dry, cool summers, and striking skyline, which makes for a wonderful place to live or to work.  All Bay Area transportation methods are easily assessible,  great affordable neighborhoods, which makes for an ideal location for AstraZeneca.   We are dedicated to creating a culture of inclusion and collaboration.

Summary of the group:

The Human Factors Engineering Group provides human factors expertise and leads human factors engineering work on device development project teams developing drug delivery devices. The Human Factors Engineers 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. 

Main Duties & Responsibilities:

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 & Experience Requirements:

Degree in human factors engineering, bioengineering, mechanical engineering, or related discipline. Years of required experience will vary based on the highest level of education completed, the level of expertise within combination products.

Bachelors Degree and a minimum of 12 years of related experience with at least 3 years of experience in applying Human Factors engineering to medical device or combination product development

OR

Masters Degree and a minimum of 10 years of related experience with at least 3 years of experience in applying Human Factors engineering to medical device or combination product development

Required Skills:

  • Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidance 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

Desired Skills:

  • Ability to communicate effectively in writing, verbally, and as a presenter
  • Demonstrated team 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

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Check out our landing page for more information on our BPD group  https://careers.astrazeneca.com/bpd

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Отличная корпоративная культура, отличные рабочие условия, поддерживающий менеджмент. Возможность ротации внутри компании. Они ценят инклюзивность и разнообразие.