Are you a seasoned professional in the field of Human Factors within the medical device industry? If you're passionate about applying your expertise to make a significant impact in a company that is committed to following science and turning ideas into life-changing medicines, then AstraZeneca's Human Factors (HF) - Associate Principal Engineer position might be the perfect fit for you!
What you will do:

• Responsible for developing human factors engineering strategies and leading HF activities on device development and drug-device combination product program teams.
• Conduct a comprehensive use-related risk analysis to ensure all use-related risks have been mitigated and reduced to an acceptable level.
• Assist in defining user needs and translating these needs into platform and combination product design requirements.
• Involve analyzing data from usability studies to inform design, inform risk mitigation, and provide alternative solutions.
• Authoring HF work you're doing for device design history files. Writing HF sections for health authority submissions and written responses
• Interact with health authorities during face-to-face meetings and in written responses.

Minimum Qualifications:

• Bachelor's Degree and a minimum of 15 years of related experience with at least 5 years of experience in applying Human Factors engineering 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 communicating how study results can be implemented into the design
• Understanding of Good Manufacturing Practices (GMP)
• Experience collaborating with external Human Factors vendors
• Experience in writing accurate, clear, and concise protocols, reports, and regulatory submissions consistent with health authority expectations

Preferred Qualifications:

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we are more than one of the world's leading pharmaceutical companies. We are a global, science-led, patient-focused biopharmaceutical company focusing on discovering, developing, and commercializing prescription medicines for some of the world's most serious diseases. Our mission is to develop innovative therapeutics for respiratory diseases and conditions including asthma and COPD. This is an exciting time to join us as we continuously seek new and better ways to deliver medicines to our patients. Our resilience helps us to thrive as we innovate and evolve.
Are you ready to make a bigger impact on patients? Here at AstraZeneca, you can feel a strong connection to the patient. It's what drives us every day. We are united behind one mission: finding the best solution to put our patients first. Play a critical role in making this happen, delivering our innovative medicines until they reach our patients.
Apply now and join us in our mission to create life-changing medicines!
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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.