Senior Human Factors Engineer

3 weeks ago

Gaithersburg, United States AstraZeneca Full time

Senior Human Factors Engineer 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 place 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.

Summary of the group: The Human Factors Engineering Group provides human factors (HF) expertise and leads human factors engineering (HFE) work on device development project teams developing drug delivery systems. The Human Factors Engineer may support more senior Human Factors Engineers, and/or directly collaborate with cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to develop drug device combination products and ensure these products are safe and effective for use.

Main Duties & Responsibilities: The candidate will be responsible for the following activities: Developing HFE strategies and leading/supporting HF activities on drug delivery device technology development and/or drug-device combination product program teams from early-stage development to new product introduction and support for on-market products. This includes ethnography, requirements definition research, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies.

Authoring HF deliverables for device design history files. Writing HF sections for health authority submissions and written responses.

Interacting with other HF group members and senior leaders with regards to HF strategy and implementation.

Improving internal HFE processes at AstraZeneca to ensure consistency, compliance and efficiency

Education & Experience Requirements: Education:

Bachelor's or Master's Degree in human factors engineering, bioengineering, mechanical engineering, or related field

Experience: Bachelor's Degree and 10+ years of related experience with 3+ years of experience in applying human factors engineering to medical device or combination product development -OR- Master's Degree and 8+ years of related experience with 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 guidances for medical devices and combination products and how to integrate into end-to-end combination product development

Designing, planning, and implementing ethnographic, formative, or summative usability studies, with or without the support of external consultancies

Demonstrated ability to translate multiple inputs (e.g., study results, technical constraints, etc.) into user needs and/or design recommendations

Proven ability to collaborate actively and proactively with others cross-functionally, particularly to champion initiatives or establish processes, with strong interpersonal skills

High level of initiative and ability to work independently

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 time management, critical thinking, decision-making, and organization skills

Complex problem-solving, root cause investigation, and technical development methodologies

Experience with development of promotional instructional materials and patient support programs for new product introductions and on-market product support based on understanding of the patient journey and passion to improve the experience with our products

Working knowledge of periodic risk review and change control processes for on-market drug-device combination products

Ability to adapt to a rapidly changing environment

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 recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a biopharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

When we put unexpected teams in the same room, we spark bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need 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.

Date Posted 18-Apr-2024 Closing Date Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. #J-18808-Ljbffr

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