Senior Device 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 one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being daring, 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 crafts life-changing medicines for people around the world.  This campus employs more than 3,500 authorities 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 groundbreaking technology and lab spaces, all crafted to encourage collaboration and multi-functional science. We believe employees benefit from being challenged encouraged at work. We are dedicated to crafting a culture of inclusion and collaboration.

The Gaithersburg site offers a variety of amenities to help boost efficiency 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 in the BioPharmaceutical R&D organization and has offices in Gaithersburg, MD, Cambridge UK, and South San Francisco, CA. The group is responsible for design, development, regulatory submission and ultimately launch of drug/device combination products. The product portfolio is mainly passionate about subcutaneous drug delivery systems and several new device 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 work

• Apply engineering principles with minimal mentorship in the design and development of robust devices and drug/device combination products

• Able to independently solve sophisticated 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

• Strong solid understanding and experience with regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual’s subject area

• Identify and successfully communicate potential development risks and challenges, analyze problems following standard methodologies, provide practical solutions and lead the risk mitigation activities and contingencies

• Represent the Device Development function with internal partners as well as externally with CMOs and development partners.

• Build project timelines, identify key technical and implementation risks, and efficiently communicate to internal governance boards and partners

• Develop strategies for product and process improvement including technical and reason for opportunities, challenges, risks, and mitigations

• Contribute to regulatory submissions for device aspects of supervised drug-device combination products

Education & Experience Requirements:

• Bachelor’s degree required. Master's or higher degree preferred.

• Degree in Mechanical, Biomedical, Biochemical Engineering, or related discipline.

• BS with 5+ years, MS with 3+ years or PhD with experience in a technical role with device development engineering related role.

• Experience in drug-device combination products is highly valued.

Required Skills:

• Experience and detailed understanding of medical device development

• Validated 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 multi-functional development teams

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 bold world.

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 daring - 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 groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas 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 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.