The Director of Medical Device and Combination Products will be a key leader within the Alexion Technical Operations Organization.  They will provide technical leadership and expertise during the development, transfer and lifecycle management of medical devices and combination products. The Director will lead a team of engineers and technical specialists supporting internal manufacturing sites and Contract Manufacturing Organisations (CMOs). This role will require in-depth expertise in medical devices and drug delivery systems across a broad range of product modalities, including biologics, oligonucleotides, peptides, and small molecules.

You will be responsible for:

• Provide technical leadership in the development, transfer and commercialization of medical devices and combination products, including autoinjectors, accessorized pre-filled syringes, pen injectors and on-body delivery systems.
• Lead and mentor a team of engineers and technical specialists providing support for global and internal site projects.
• Partner with Device Development, Receiving Site, Drug Product partners, Quality and Regulatory to plan and execute Design Transfer of medical device and combination products in clinical or commercial phase.
• Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design and to ensure early engagement and alignment with manufacturing.
• Provide leadership and direction for technical support of ongoing changes to medical device and combination product designs and manufacturing processes, and provide expert technical support for significant investigations and complaints
• Apply expertise in design controls, device risk management and control strategies to ensure quality and reliability throughout the product lifecycle.
• Stay up to date on technological advancements in the manufacturing of medical devices and combination products, evaluating and implementing appropriate innovative solutions to enhance operational capabilities.
• Collaborate with commercial teams to enable successful product launch initiatives.
• Collaborate with cross-functional teams to ensure that all products meet safety, efficacy, and quality, and robust supply standards throughout their lifecycle.

You will need to have:

• Bachelor’s degree in engineering, life science or related field.
• More than 10 years experience in medical device or combination product engineering, with at least 5 years in a leadership role.
• Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and packaging, with specific experience in autoinjectors and accessorized pre-filled syringes.
• Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.
• In-depth knowledge of regulatory requirements governing the manufacturing of medical device or combination products, including FDA regulations and ISO standards.
• Proven track record of leading cross-functional teams.
• Excellent communication and negotiation skills, with the ability to manage and mentor engineers and technical specialists.

We would prefer for you to have:

• Advanced degree (Masters or PhD) in Engineering or Life Sciences.
• Lean Six-Sigma certification.

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.