Director, Device Development

Job Title Director Device Development

Introduction to role

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

Accountabilities

• 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.

Essential Skills/Experience

• 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).

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role employees must be able with or without accommodation to use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience

• Bachelors Masters or PhD Degree in Engineering (Electrical Engineering Biomedical Mechanical or Chemical) plus 12-18-year experience in medical device development.

The annual base pay (or hourly rate of compensation) for this position ranges from 175498.40 - 263247.60 USD Annual (80% - 120%).Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca offers the chance to work at the forefront of rare disease biopharma where complex biology is translated into transformative medicines for people living with devastating conditions. With the resources and reach of a global organization combined with the energy of a biotech environment teams explore rare opportunities in new areas of unmet need while staying close to patients lived experiences. Colleagues are encouraged to innovate learn fast collaborate across disciplines and grow through tailored development that aligns personal ambitions with a powerful shared purpose: changing lives every day.

If this role resonates and the mission inspires action apply now to take the next step in your journey with us.