Director, Device Development

AstraZeneca•Boston, MA

1d•Hybrid

About The Position

This Director/Senior Director position leads Device Development for Alexion products within the Global Product Development function, with a strong focus on continuous product improvement. The role directs complex projects and device development engineering teams to deliver robust Design Control, Laboratory and Device Engineering support for operational activities. It oversees engineering testing, documentation, and inspection activities to ensure safe, reliable, and compliant drug-device combination products reach patients who need them most. Ready to shape how life-changing medicines are delivered?

Requirements

A minimum of 10 years of experience in drug device combination product/device development and commercialization
Experience of commercialization of mechanical or electro-mechanical injection systems or similar drug delivery presentation.
Direct cross-functional program management experience in the development and commercialization of device branded products.
Demonstrated success leading multi-site, global or enterprise-wide programs in the biotech/ pharmaceutical industry.
Experience in interacting with R&D to understand early Device/Combination product needs and develop roadmaps.
Working experience in phase-based design control activities with integrated risk management deliverables and human factors/usability engineering studies, from research through registration, launch, and life cycle management.
Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base.
Strong communication, collaboration, and team building skills; ability to connect with all levels of the organization.
Proficient in writing internal reports, project summaries, and internal/external presentations
Deep knowledge of the performance, safety and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g. ISO 11608 series, ISO 14971, IEC 60601 series, IEC 62304, FDA QSR 21 CFR Part 4 and 820 / ISO13485 quality system requirements, and related FDA guidance).

Nice To Haves

Bachelor’s, Master’s, or PhD Degree in Engineering (Electrical Engineering, Biomedical, Mechanical, or Chemical), plus 12-18-year experience in medical device development.

Responsibilities

Lead and manage complex cross-functional projects involving regional and global teams, ensuring alignment on objectives, priorities, and delivery plans.
Build and maintain strong cross-functional relationships, including clear escalation paths with Quality, Regulatory, Manufacturing, and Supply Chain to resolve issues quickly and effectively.
Drive senior leader stakeholder communication, updates, and governance committee interactions to secure visibility, endorsement, and resources for key programs.
Develop and own project strategies in partnership with CMC, Global Project Leads, and other stakeholders, translating product needs into executable device development roadmaps.
Manage strategic external partner relationships for specific technologies, resources, and expertise, ensuring high-quality outcomes and value.
Mentor and/or manage a device engineering subteam covering design, design verification testing, and industrialization to support integrated design control from clinical development through registration and commercial supply.
Conduct deep technical and compliance reviews with engineers to challenge assumptions, strengthen designs, and protect timelines.
Ensure all project timelines and activities comply with company quality assurance standards and applicable global regulatory requirements.
Provide clear feedback on performance and ensure development plans are defined, tracked, and executed for team members.
Champion a culture of scientific rigor, problem-solving, and continuous improvement across device development activities.