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 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 youre 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 3500 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 cutting-edge 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 youll 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 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 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 cross functional CMC and device development teams to meet program deliverables

• Apply engineering principles with minimal oversight 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 individuals discipline

• Identify and effectively communicate potential development risks and challenges analyze problems following best practices provide practical solutions and manage the risk mitigation activities and contingencies

• Represent the Device Development function with internal stakeholders 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 stakeholders

• 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:

• Bachelors degree and 3 years experience or Masters and 2 years experience

• Degree in Mechanical Biomedical Biochemical Engineering or related discipline.

• BS or MS with 3 years 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 cross 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 were opening new ways to work pioneering cutting edge methods and bringing unexpected teams together. Interested Come and join our journey.

The annual base salary for this position ranges from $80653.60 - 120980.40 USD Annual

However base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

So whats next!