Are you a seasoned professional in the field of Human Factors (HF) Engineering, particularly within the medical device industry? If so, AstraZeneca is looking for you! 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. We are more than one of the world's leading pharmaceutical companies. We are a team of pioneers, innovators, and change-makers.
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.
This role will be filled at either a Human Factors Engineer or Sr. Human Factors Engineer commensurate with experience and capabilities.
What you will do:
As a Human Factors / Sr. Human Factors Engineer, you will be leading HF activities on device development and drug-device combination product program teams.

• Conduct comprehensive use-related risk analysis to ensure all use-related risks have been mitigated and reduced to an acceptable level,
• Conduct formative and summative studies.
• Assist in defining user needs and translation of needs into platform and combination product design requirements.
• Analyze 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

Minimum Qualifications:

• Bachelor's degree required in human factors engineering, bioengineering, mechanical engineering, or related field. Years of required experience will vary based on the highest level of education completed, and the level of expertise within combination products.
• Engineer: Minimum 5 years of related experience or Master's Degree and a minimum of 2 years of related experience in applying human factors engineering to medical device or combination product development
• Sr. Engineer: 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 -OR- Master's Degree and a minimum of 8 years of related experience with at least 3 years of experience in applying human factors engineering to medical device or combination product development.
• Experience collaborating with external Human Factors vendors.
• Experience writing accurate, clear, and concise protocols, reports, and regulatory submissions consistent with health authority expectations.
• Knowledge of human factors standards, including HE75, IEC 62366, FDA guidance for Human Factors and Usability Engineer, ISO 14971.

Preferred Qualifications:

• Experience with drug-device combination products.
• Experience with inhaler device products.

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.
Why AstraZeneca?
At AstraZeneca, we are driven by innovation and our commitment to deliver life-changing medicines to patients worldwide. Our Supply Chain team is a diverse group of experts who are connected across the globe. We interpret the science, connecting it with the business need to apply manufacturing excellence. We foster an encouraging, positive environment where ideas are welcomed and rewarded. We are active players in growth and evolution with a clear long-term strategy. As a global business in stable growth, there are long-term opportunities and multiple pathways to take.
Ready to make a big impact? Join us today and be part of our mission to create better outcomes for our patients!
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.