Device Engineer, Senior Specialist

This is what you will do:

The Device Engineer, Senior Specialist is responsible for technical support of device/finished product manufacturing for commercial products and provides device engineering support through all phases of the commercial device/finished product (FP) lifecycle. This includes design transfer, validation, and routine device/FP commercial manufacturing.

Serves as a subject matter expert for the FP aspects of device assembly and device activation for external device/FP manufacturing for Alexion commercial products applying drug delivery devices as the programs/products transition into commercial products.

You will be responsible for:

• Collaborate with R&D during development to ensure product & process requirements are identified, and robust specifications are generated.
• Perform Device/Finished Product (FP) design transfer for assigned projects into cGMP commercial external device/FP manufacturing facilities.
• Perform process evaluation, facility fit analysis and identification of equipment required for new device/FP manufacturing processes, either independently or in partnership with external device/FP manufacturing personnel.
• Support alignment of device/FP processes across internal and external device/FP manufacturing sites.
• Support resolution of complaints and liaise with device vendor(s) to resolve issues, investigations, and implement continuous improvements. 
• Author / review device/FP design transfer documentation; e.g. validation run protocols, and technical study protocols.
• Provide device/FP SME input for regulatory agency submission in support of device/FP manufacturing process operated at external FP manufacturing sites.
• Perform technical assessments to support business needs e.g. non-conformities, deviations, CAPA and change management (design, process and document changes)
• Provide device engineering expertise in trouble shooting activities to support manufacturing during device/FP design transfer activities or routine device/FP manufacturing.
• Identify and lead device/FP process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of device/FP and device assembly manufacturing.
• Identify device/FP manufacturing best practices across the network and lead or participate in teams to implement best practices.
• Collaborate effectively with other team members in cross functional technology transfer teams, including with device/FP external manufacturing partners and internal device/FP manufacturing stakeholders.
• Implement business process improvements with a continuous improvement mindset for device/FP manufacturing support and device/FP tech transfers.
• Partner with product teams on optimal device design considering the end user/patient, supply chain, and device/FP manufacturing network capabilities.
• Partner, own and provide input with business partners on the development and maintenance of stage relevant device and combination product lifecycle documents..
• Partner with quality on maintaining lifecycle documents for devices and combination products.

You will need to have:

• Minimum of Bachelor’s degree in Engineering (or similar technical degree)
• Experience in providing technical support to device manufacturing (technology transfer or routine cGMP manufacturing).
• Good understanding of cGMP requirements for commercial device manufacturing and the lifecycle management of combination products and medical devices (e.g. ISO 13485. ISO 14971, 21CFRPart4/21CFR820 and EUMDR).

We would prefer for you to have:

• Comprehensive knowledge of device/Finished Product manufacturing operations including pre-filled cartridges, injection pens, combination products and design control/technical documentation.
• Advanced degree in a related field.

Competencies

• Flexibility and strong attitude toward teamwork and collaboration, with ability to build effective relationships.
• Design Control
• Process validation
• Manufacturing processes
• Basic statistical tools
• Design/Technology Transfer

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.