Associate Director Principal Engineer, Device Development

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