Job Title: Device Development Lead

Location: Cambridge

Contract Term: 23 months

Hours: 37 hours p/w

Job Function: Engineering, Project Engineering, Project Management

Role Overview:

This role sits within the Biotherapeutics Pharmaceutical R&D Devices Centre of Excellence (DCoE) in Cambridge. The Device Development Lead is responsible for leading the development of medical devices and combination products (MDCPs) from concept through regulatory approval across global markets.

The role requires leadership of cross-functional teams, management of external partners, and full accountability for quality, cost, and schedule throughout the product lifecycle.

Key Responsibilities:

Project & Technical Leadership

• Lead multi-disciplinary teams in the development and lifecycle management of drug delivery devices.
• Own end-to-end device development activities including device specifications, concept evaluation, design development, design control, risk management, verification & validation, and industrialization.
• Ensure projects meet quality, cost, and timeline objectives.
• Act as technical Subject Matter Expert (SME) for device technologies.

Design Control & Regulatory Compliance

• Apply design control and risk management principles (ISO 13485, ISO 14971, ISO 62366, GMP).
• Ensure compliance with global regulatory requirements including EU MDR.
• Support preparation of regulatory documentation (IND, BLA, NDA, ANDA, etc.).
• Support device design change control processes.
• Contribute to complaint investigations and device-related technical issues (clinical & commercial).

Cross-Functional & External Collaboration

• Collaborate with drug product development, manufacturing (PGS), Quality Assurance, Regulatory (GCMC), and Global Technical & Engineering (GT&E).
• Manage external design houses and contract manufacturers.
• Support supplier assessment and quality system evaluations.
• Provide input to supplier specifications and usability studies (human factors).

Operational & Strategic Support

• Support budget planning and long-range resource planning.
• Mentor and coach team members.
• Contribute to performance assessment strategies for drug-device combinations.
• Identify emerging industry trends and technologies.

Education & Experience:

• Degree or equivalent in Engineering or relevant technical discipline.
• 8–10+ years’ experience in medical device or combination product development.
• Proven experience leading multi-disciplinary teams.
• Experience managing product development from concept to commercialization.
• Strong knowledge of Design Control principles, ISO 13485, ISO 14971, ISO 62366, GMP, and EU Medical Device Regulations.
• Experience contributing to global regulatory submissions (BLA, MAA, IND, CTD, etc.).

Technical Expertise

Required:

• End-to-end product development lifecycle knowledge
• Project planning tools & methodologies
• Design Control systems
• ISO 13485 compliance

Preferred:

• Risk assessment tools (e.g., FMEA)
• Injection molding processes
• Automated assembly/testing systems
• Drug delivery or needle injection systems

Key Competencies

• Strong decision-making and analytical capability
• Ability to manage multiple priorities simultaneously
• Excellent stakeholder management and communication skills
• Accountable, resilient, and adaptable
• Practical, pragmatic problem-solving approach