The Engineer will lead or make strong technical contributions within cross functional combination product development teams and/or to complex technical development and problem-solving projects. This role will be responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs. To be successful the candidate must effectively interface with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development and Astra Zeneca. Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management / Leaders, health authorities, audits and other internal and external stakeholders. This role will lead technical development with external development and commercialization partners and component suppliers and problem-solving activities using state of the art tools and techniques such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design, etc. Development and commercialization 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
- Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and/or commercialization of drug delivery devices for the AZ pipeline
- Be a senior scientific contributor to complex problem solving and technical development
- Contribute to departmental combination product development capability by applying and maintaining a high level of knowledge and expertise
- Influence and educate cross-functional stakeholders and leaders on device development and commercialization best practices
- Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborations
- Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (e.g. risk management, Design Controls, ISO standards etc.)
- Contribute to regulatory filings and health authority responses
- Develop and implement best practices / business processes
- Engineering or technical degree or equivalent. BS required, MS or PhD preferred.
- Engineer: A minimum of 2 years of experience in technical roles within combination product development.
Other Skills and Qualifications:
- Excellent leadership skills to lead a cross functional team and ensure success of the project.
- Experience in working with external development and commercialization partners and suppliers is highly desirable.
- A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.
- Excellent communication skills are required.
- Familiarity with industry standards and practices applicable to device and/or combination product development is required.
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 authorisation and employment eligibility verification requirements.