Associate Director Principal Engineer, Device Development Position Available In Suffolk, Massachusetts

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. Introduction to

Role:

An Associate Director/Associate Principal Engineer in Device Development leads parenteral combination product development activities from early stage innovation through clinical development and launch. Typical development work includes leading technology selection/characterization, leading combination product development for clinical and commercial applications; 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. The position includes direct leadership of device teams as well as mentorship of junior engineers. The incumbent will work cross-functionally with both internal staff and leaders across Development, Quality, Regulatory, Commercial, Operations, and with CMC Teams, and Global Product Teams (GPTs).

Accountabilities:

Lead large cross functional teams/programs. Provides support to junior staff Subject matter expert in engineering principles for the design and development of robust parenteral devices that meet patient, molecule, and business needs. Expert knowledge of regulations and standards such as design controls, risk management, and industry standards specific to parenteral devices (e.g. prefilled syringes, autoinjectors, pens) Strategic program management with oversight to cross functional program decisions and risks. Anticipates potential design/process problems, analyzes problems following best practices, 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 suppliers Establishes 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 function Expertise 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 sigma Represents the function in senior review forums Ensures compliance of own work and the work of others within established Safety, Health, and Environment standards

Essential Skills/Experience:

Bachelors Degree and a minimum of 13 years of related experience. Masters Degree and a minimum of 10 years of related experience or PhD and a minimum of 8 years of related experience. The candidate should have at least 8 years of experience in parenteral combination product development Experience in the following areas: parenterals device technologies, combination product development, human factors, methods development, device/process characterization, design controls, risk management, process development Understanding of cross functional product development Communication skills (both written and oral) to summarize development work, critical conclusions and it’s relevance to the larger program Knowledge of procedures and compliance with Good Manufacturing Practice & Safety, Health and Environment requirements Knowledge and understanding of device/process development

Desirable Skills/Experience:

Substantial post graduate 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. #LI-Hybrid Date Posted 23-Jun-2025 Closing Date 26-Jun-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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.