Senior Device Engineer | Gaithersburg, MD

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 Astra Zeneca 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 pioneering technology and lab spaces, all designed to inspire collaboration and multi-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 increasing collaboration between teams. Summary of the group: The Device Development Group in the Biomedical 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 focused on 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 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 Strong working knowledge and experience with regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual's discipline Identify and effectively communicate potential development risks and challenges, analyze problems following best practices, 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.

Create project timelines, identify key technical and implementation risks, and effectively communicate to internal governance boards and partners Develop strategies for product and process improvement including technical and business case for opportunities, challenges, risks, and mitigations Contribute to regulatory submissions for device aspects of regulated 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 Ph D 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 thorough 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 multi-functional development teams Why Astra Zeneca?

At Astra Zeneca 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-medical 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 careers. /bpd Our Social Media, Follow Astra Zeneca on Linked In /company/1603/ Follow Astra Zeneca on Facebook /astrazenecacareers/ Follow Astra Zeneca on Instagram /astrazeneca_careers/? hl=en Date Posted 01-Nov-2023 Closing Date Astra Zeneca 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 (e. g. race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability or protected veteran status). We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. Astra Zeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.