# Director, Device Development

**Company**: Device Development
**Location**: Boston, Massachusetts, United States of America
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $175,498.40 - $263,247.60
**Category**: Engineering
**Industry**: Healthcare

**Apply**: https://astrazeneca.eightfold.ai/careers/job/563877689992247
**Canonical**: https://yubhub.co/jobs/job_68fff2de-5f2

## Description

Ready to shape how life-changing medicines are delivered?

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.

Key responsibilities include:

- Leading and managing complex cross-functional projects involving regional and global teams, ensuring alignment on objectives, priorities, and delivery plans.

- Building and maintaining strong cross-functional relationships, including clear escalation paths with Quality, Regulatory, Manufacturing, and Supply Chain to resolve issues quickly and effectively.

- Driving senior leader stakeholder communication, updates, and governance committee interactions to secure visibility, endorsement, and resources for key programs.

- Developing and owning project strategies in partnership with CMC, Global Project Leads, and other stakeholders, translating product needs into executable device development roadmaps.

- Managing strategic external partner relationships for specific technologies, resources, and expertise, ensuring high-quality outcomes and value.

- Mentoring and/or managing a device engineering subteam covering design, design verification testing, and industrialization to support integrated design control from clinical development through registration and commercial supply.

- Conducting deep technical and compliance reviews with engineers to challenge assumptions, strengthen designs, and protect timelines.

- Ensuring all project timelines and activities comply with company quality assurance standards and applicable global regulatory requirements.

- Providing clear feedback on performance and ensuring development plans are defined, tracked, and executed for team members.

- Championing a culture of scientific rigor, problem-solving, and continuous improvement across device development activities.

Essential skills and experience include:

- 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.

Desirable skills and experience include:

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

The annual base pay for this position ranges from $175,498.40 to $263,247.60. Our positions offer eligibility for various incentives, including short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.

Benefits offered include qualified retirement programs, paid time off, and health, dental, and vision coverage in accordance with the terms of the applicable plans.

Join us in our unique and ambitious world, where complex biology is translated into transformative medicines for people living with devastating conditions. 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.

## Skills

### Required
- drug device combination product/device development and commercialization
- 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
- strong communication, collaboration, and team building skills
- proficient in writing internal reports, project summaries, and internal/external presentations

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