Job Title: Director, Device Development
Location: Boston, MA

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. 

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. 

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. 

As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here: Kendall Square Press Release

Introduction to Role:

The Device Project Management Group drives AstraZeneca device project delivery, supporting clinical studies and commercial launch. Device Project managers plan, coordinate, and deliver Device activities in line with project requirements and timelines; plan and monitor resources and expenses for product development; and perform strategic planning for platform and novel processes. The group interfaces globally with the CMC team, Drug Product team, Operations, Quality, Regulatory, and all development functions.

In this role, you will lead the design, development, and implementation of biopharmaceutical devices and will implement based on a deep understanding of engineering fundamentals, product requirements, and business needs. Typical development work includes leading technology selection, technology characterization, leading combination products for clinical and commercial applications; implementing robust engineering tools like simulation based mechanistic and statistical models, design controls and risk management compliance; strategic engagement with external vendors and CMOs, and appropriate sequencing and interpretation of development work to ensure program goals are met.

Accountabilities:

Lead large multi-functional teams/programs. Provides support to junior staffAuthority in engineering principles for the design and development of robust devices/methods/processes that meet patient, molecule, and business needs.Expert knowledge of regulations and standards such as design controls, risk management, human factors and industry standards specific to an individual’s fieldStrategic program management and overseeing multi-functional program decisions and risks. Anticipates potential design/process problems, analyzes problems following standard methodologies, provides practical solutions and manages the consequences of any failures. Demonstrated ability to lead and integrate technologies/processes in the development, scale up and commercialization of complex multicomponent products that will be manufactured across a global network of suppliersEstablishes frequent inter and intradepartmental collaborations that expand business opportunities for the company, improves the efficiency and effectiveness with which we operate and provide development opportunities within the functionExpertise in solving complex problems using tools such as: engineering modelling 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 sigmaRepresents the function in senior review forumsEnsures compliance of own work and the work of others within established Safety, Health, and Environment standards

Essential Skills/Experience:

Bachelors Degree in a related field8+ years of experience in medical device or combination product development.Experience in the following areas: new device technology development, combination product development, human factors, methods development, device/process characterization, design controls, risk management, process developmentUnderstanding of multi-functional product developmentCommunication skills (both written and oral) to summarize development work, critical conclusions and it’s relevance to the larger programKnowledge of procedures and compliance with Good Manufacturing Practice & Safety, Health and Environment requirements Knowledge and understanding of device/process development

Desirable Skills/Experience:

Masters Degree in a related field5+ years of experience in medical device or combination product development.Experience in parenteral device/process development

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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Date Posted

30-Jan-2025

Closing Date

12-Feb-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.