Do you have Human Factors experience in the medical device industry? Would you like to apply your expertise to impact a company that follows science and turns ideas into life-changing medicines? Then AstraZeneca's Sr. Human Factors Engineer position might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies

Be part of leading our Development function at an exciting time of growth and evolution. We pioneer new approaches and processes across our sites, empowering our teams to foster a Lean mindset and sustainable practices. Every change we make is to deliver better outcomes for our patients.

AstraZeneca Durham has expanded and strengthened its respiratory products portfolio, delivering approvals and launches for multiple global inhalation products, with a robust pipeline in development. Our mission, through dedication to creating a culture of inclusion and teamwork, is to develop innovative therapeutics for respiratory diseases and conditions including asthma and COPD. . This site is responsible for the product, device, process, and analytical development of new inhalation products in the AZ portfolio. The site also manufactures and packages clinical supplies to meet clinical trial demands. Join us in Durham, NC, which is situated in Research Triangle Park; the leading center of innovation in the Southeast!

What you will do:

• Developing human factors engineering strategies and leading HF activities on device development and drug-device combination product program teams, conducting comprehensive use-related risk analysis to ensure all use-related risks have been mitigated and reduced to an acceptable level, and conducting formative and summative studies

• Assisting in defining user needs and translation of needs into platform and combination product design requirements

• Analyzing data from usability studies to inform design, inform risk mitigation and provide alternative solutions

• Writing and reviewing HF sections for health authority submissions and interacting with health authorities during face-to-face meetings and in written responses.

• Participating in design control activities for inhalation drug-device combination product development to ensure compliance with 21 CFR 820. Requires good leadership and collaboration skills

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

Qualifications:

Education:

• Bachelor's Degree in human factors engineering, bioengineering, system engineering, mechanical engineering, or related discipline required.

Required:

• Bachelors Degree and a minimum of 8 years of related experience with at least 3 years of experience in applying Human Factors engineering medical device or combination product development OR

• Masters Degree and a minimum of 6 years of related experience with at least 3 years of experience in applying Human Factors engineering to medical device or combination product development

• Knowledge of human factors standards, including HE75, IEC 62366, FDA guidance for Human Factors and Usability Engineer, ISO 14971, and working cross-functionally on risk management activities and design controls per 21 CFR 820

• Consistent track record in analyzing data and clearly communicate how study results can be implemented into the design

• Understanding of Good Manufacturing Practices (GMP)

• Experience collaborating with external Human Factors vendors

• Experience to write accurate, clear, and concise protocols, reports, and regulatory submissions consistent with health authority expectations

Desired:

• Experience with electro-mechanical and connected devices, drug-device combination products, inhaler devices, and Device development

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

The challenge to stay ahead in rapidly changing markets is what keeps us driving forward, as we continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve.

So, what's next?

Are you ready to bring new ideas and fresh thinking to the table? Wonderful!

More on Social Media:

• LinkedIn https://www.linkedin.com/company/1603/

• Facebook https://www.facebook.com/astrazenecacareers/

• Instagram https://www.instagram.com/astrazeneca/?hl=en

• About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.