Device Engineer - BPD

Gaithersburg, Maryland

Posted in Pharmaceuticals

This job has expired.

Job Info

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 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 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:

Device Development provides combination product expertise to the development of drug-delivery parenteral for the expanding Astra Zeneca pipeline. We are seeking a device engineer to join the Device Functionality and Safety team. The group consists of people with a diverse range of technical backgrounds including device engineers, people with equipment and test method development expertise, design controls skills and more and is responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs. The team is working on characterization, evaluation, and design verification of combination devices and novel technologies.

Main Duties & Responsibilities:

  • Design, develop and execute experiments (DOE) for device characterization and evaluation with minimum supervision.
  • Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOP, protocols, and reports with minimum supervision and deliver timely, high quality data and interpretations to drive key scientific solutions.
  • Is expected to be familiar with medical device development and preferably combination devices.
  • Establish and maintain a close working relationship with equipment vendors and contribute to oversite of external collaboration partners. Liaise effectively with internal departments (Quality, Regulatory, Operations, etc...).
  • Be an skilled user of device engineering and testing software/tool/equipment such as the tensile test machine (INSTRON), confocal and/or light microscopy, Solidworks, Minitab, and etc.
  • Develop process descriptions to standardize testing procedures across analysts and innovate, develop and evaluate device characterization techniques and technologies as they relate to device development requirements.
  • Perform test method qualification and method transfer to GMP testing group in support of device verification & validation testing.
  • Establish and foster a strong collaborative working relationship with internal departments and external vendors/suppliers and ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. - USP/PharmEur, ISO /MDD/GMP/GLP, 21CRF Part 4 & 820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards.

Education & Experience Requirements:

B.S. or M.S. degree in Mechanical/Biomedical/Chemical Engineering, Pharmacy, Pharmaceutical Sciences, or related field.

Bachelor's degree with 4+ years of experience OR Master's degree with 2+ years of experience with combination products and/or medical device technologies.

Required Skills:
  • Medical device design - Design Controls
  • Combination products
  • Regulatory filing of pharmaceutical products
  • Mechanical testing
  • 3D model and rapid prototyping

Desired Skills:
  • Medical Device Development, Combination Products
  • Design Controls
  • Validation/Verification

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 cutting edge 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

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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.

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

This job has expired.

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