Senior Device Engineer
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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 one 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.
About AstraZeneca in Gaithersburg, MD:
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most ground breaking technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while growing collaboration between teams.
Summary of the group:
The Device Development Group sits in the BioPharmaceutical R&D organization and has offices in Gaithersburg, MD and South San Francisco, CA. The group is responsible for design, development, healthcare authority approval and ultimately launch of drug/device combination products. The product portfolio is mainly focused on subcutaneous drug delivery system, and also have several new Technology Development projects in other related areas.
Main Duties & Responsibilities:
High functioning technical and collaborative member of multi-functional CMC and device development teams to meet program deliverables
Apply engineering principles with minimal guidance in the design and development of robust devices and drug/device combination products
Able to independently solve complex problems using tools such as: engineering modeling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, usability engineering tools, design for manufacturability/assembly techniques and design for six sigma
Has a solid understanding and experience with regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual's field
Identify and effectively communicate potential development risks and challenges, analyze problems following standard methodologies, provide practical solutions and manage the risk mitigation activities and contingencies
Represent the Device Development function internally as well as externally with CMOs and development partners.
Education & Experience Requirements:
Bachelor's degree in Mechanical or Biochemical Engineering, or related field required. Master's or higher degree preferred.
BS with at least 5 years of experience or MS with a minimum of 3 years of experience in a technical role with device development engineering related role.
Required Skills:
Experience and detailed understanding of medical device development
Demonstrated experience of product characterization, design controls and risk management
Extensive experience of working in a multi-functional product development environment
Excellent communication skills (both written and oral) to summarize development work, critical conclusions and its relevance to the bigger picture
Demonstrated experience in one or several of the following areas: new technology development, process development, combination product development, human factors, test methods development, device/process characterization, design controls, risk management
Desired Skills:
Experience in development of drug/device combination products for subcutaneous delivery
Technical leadership of cross-functional development teams
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 recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering innovative methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next?
Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours.
Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
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AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.