Director

Description:

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

The successful candidate will be a strong voice of user/patient centricity across AstraZeneca. This candidate will be responsible for the human factors engineering group. They will build strong relationships and collaborate with cross functional leaders in development, regulatory, quality, clinical, commercial, and operations, to guide development of combination products and ensure these products are safe and effective for use.

Main Duties & Responsibilities:

• Lead Human Factors efforts for combination product and new technology development including ethnography, requirements definition research, formative studies, instruction and training development, risk analysis and summative studies.

• Write and review HF sections for health authority submissions.

• Interact with health authorities during face to face meetings and in written responses.

• Engage AstraZeneca senior leaders in development, quality, regulatory, clinical, commercial and operations with regards to HF strategy, implementation and standard processes.

• Manage HF engineers and mentor the group professionally.

• Be a voice of user centricity across all product types in AstraZeneca.

• Be engaged with and influence Human Factors standard processes externally across industry and with regulators

• Improving internal Human Factors processes to ensure consistency, compliance and efficiency

Education & Experience Requirements:

Degree in human factors engineering, mechanical engineering, bioengineering or related field is required. 10+ years’ experience in combination product or medical device development, with at least 7 years focused on human factors engineering (HFE). They will have demonstrated the ability to support the HFE activities described above.

Required Skills:

• Strong depth of knowledge in Human Factors engineering including a working knowledge of US/EU guidances and standards related to human factors/usability, design controls and risk management. Ability to adapt human factors strategies to the evolving regulatory expectations in this space

• Strong communication skills with an ability to influence internal partners as well as external industry and health authorities

• Ability to lead a global team, create a positive work environment and effectively develop staff