Device Engineer

AstraZeneca is a global, innovation-driven bio-pharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have an outstanding workplace culture that encourages innovation and collaboration. Here, employees are empowered to express different perspectives and are made to feel valued, energised and rewarded for their ideas and creativity. As the "Device Engineer" you will lead and/or make strong technical contributions within multi-functional Combination Product Commercialization and On Market Technical (OMT) support teams. You'll be responsible for successful OMT support for Parenteral Combination Products including design, development, manufacturing and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs. To be successful we would like you to be effective in working with staff and leaders in Operations, Global External Sourcing, Global Supplier Quality, Device Development, Device Quality, Regulatory Affairs and across other areas in AstraZeneca. Strong communication skills are required including succinct and effective presentation of technical materials during technical meetings. This role will support and/or lead technical activities related to manufacturing, feasibility, design changes and commercialization with both internal and external partners, including Device suppliers. Problem Solving, Design Changes, and commercialization activities must be conducted in compliance with applicable processes / procedures, standards and regulations including Design controls, Risk management, Human factors engineering, FDA QSR, ISO13485, etc. Major Duties and Responsibilities Life cycle management of Parenteral Device Combination Products, including technical strategy, device control strategy, issue support, change implementation, knowledge management and DHF oversight. Lead or be a strong technical contributor to a multi-functional team to enable robust manufacture through the lifecycle for a wide portfolio of Parenteral Combination Products in addition to synthetic molecule device platforms as they transition into commercial supply. Authoring, maintaining and compiling Design History File content and Design Change Impact Assessments (i.e. Provide technical direction for the evaluation and implementation of changes) Design and/or provide technical studies/assessments (e.g. feasibility activities) that drive robust product/process/testing performance. Author and review technical specifications and design control documentation (Design and Development Plans, FMEAs, User Requirements Specifications, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, and Design Transfer) Drive a Quality attitude and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (e.g. risk management, Design Controls, ISO standards etc.) Ensure robust OMT support to products manufactured and tested within AZ and CMOs. Be a strong contributor to complex problem solving and technical development; development of suitable corrective and preventive actions in support of investigations. Influence and educate multi-functional partners and leaders on device development, OMT and commercialization standard methodologies Establish a close working relationship with and provide effective oversight of suppliers and lead technical aspects of external collaborations. Engage with internal and external customers and other OMT Subject Matter Experts to settle appropriate support for OMT involvement for major issues and changes (in accordance with RACIs and QCMs) to drive robust technical support and outcomes. Provide proactive product management by regularly assessing product/process/testing performance through evaluation of data (such as CPV reports and data, deviations, complaint trends, process performance, risk assessments, etc.). Acquire or continue to seek and obtain in-depth product knowledge and understanding to be able to demonstrate product, process and/or testing expertise (commensurate with the role). Education : * BS and/or MS in engineering or equivalent technical field Experience : * Validated experience of supporting Combination Products and/or Medical Devices Other Skills and Qualifications: * Knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 4, Part 820, ISO 13485, ISO 14971, Medical Device Directive 93/42/EEC), as well as other applicable standards required (ISO 11608 series, ISO 62304, etc.). * Excellent leadership skills to support and/or lead a multi-functional team and ensure success of the project. * Experience in working with external development and commercialization partners and sup