Device Development Lead

About the Role

Location: Cambridge (Hybrid Working)

Contract length: 2 years

We are seeking an experienced and motivated to lead multi-disciplinary project teams in the development and lifecycle management of drug delivery devices. This role will drive device development activities from concept through industrialisation, ensuring projects are delivered to agreed quality, cost, and schedule targets.

You will collaborate closely with drug product development, co-development, manufacturing teams, and external vendors to introduce new drug delivery devices and manage ongoing lifecycle activities. In addition, you will provide coaching and mentorship to support the development of team members.

Key Responsibilities

Leadership & Project Management

• Lead and coordinate multi-disciplinary teams and external partners to deliver device development projects.
• Manage project scope, deliverables, timelines, and budgets.
• Ensure projects meet defined targets for quality, cost, and schedule.
• Support long-range resource planning and departmental budgeting.
• Provide coaching and mentorship to develop project team members.
• Act as a Subject Matter Expert (SME) in device technologies internally and externally.

Device Development & Design Control

• Accountable for all aspects of drug delivery device development and lifecycle management activities.
• Lead activities relating to:
  • Device specifications
  • Design development
  • Concept evaluation
  • Design control
  • Risk management
  • Device industrialisation
  • Design verification & validation
• Apply design control and risk management principles to all projects.
• Support and manage device design change control systems ensuring regulatory and quality compliance.
• Provide input into supplier specifications and support supplier assessments.
• Support human factors and usability studies.
• Contribute to the assessment of device performance factors requiring investigation.

Manufacturing, Quality & Compliance

• Liaise with drug product development and manufacturing teams during device introduction and lifecycle management.
• Manage design development activities at external vendors in coordination with industrialisation.
• Support investigations related to clinical trial and commercial devices.
• Support timely resolution of device-related complaints and technical issues.
• Ensure compliance with SOPs, GxP requirements, risk assessments, and safe working practices.
• Support regulatory correspondence and filings, including IND, BLA, NDA, and ANDA submissions (multi-market).

Industry & Strategic Input

• Evaluate current and emerging industry trends to anticipate future business needs.
• Support assessment of external design companies and suppliers for quality system capability.
• Provide expert input into strategic device development initiatives.

Candidate Profile

• Proven experience in drug delivery device development within the pharmaceutical or medical device industry.
• Strong knowledge of design control, risk management, verification and validation processes.
• Experience working with external vendors and managing cross-functional teams.
• Familiarity with regulatory requirements and submissions (IND, BLA, NDA, ANDA).
• Excellent project management, leadership, and communication skills.
• Strong understanding of GxP and quality systems.