Device Development Lead

4 Days Old

Overview

This role leads the end-to-end development of medical devices and combination products, from early concept through to global regulatory approval. The Device Development Lead oversees multidisciplinary project teams, manages external design partners, ensures compliance with device regulations, and drives successful delivery of device programmes.

Key Responsibilities

Project Leadership

* Lead multidisciplinary project teams in the development of drug delivery devices and lifecycle management activities.

* Manage project scope, timelines, quality and cost across assigned device programmes.

* Coordinate closely with formulation, manufacturing and co-development teams to support integration of devices into broader product development plans.

Device Development & Design Control

* Take full accountability for all stages of device development, including:

* Concept evaluation & Design development & Risk management

* Industrialisation and transfer to manufacturing

* Apply design control principles and ensure all activities meet regulatory and quality system requirements.

* Support the device change control process and ensure timely, compliant implementation.

External Partner Management

* Manage design and development activities carried out by external design houses and contract manufacturing organisations.

* Provide input on supplier specifications, component requirements and technical capability assessments.

Regulatory & Quality Support

* Contribute to global regulatory submissions (e.g., IND, IMPD, BLA, MAA, CTD) for device components of combination products.

* Support investigations related to device performance in clinical or commercial use.

* Provide technical support for complaint investigations and device-related queries.

* Ensure all work complies with GxP, safe working practices, and relevant standards.

Human Factors & Usability

* Provide input into human factors and usability studies for new and existing device platforms.

* Ensure device performance requirements are clearly defined and appropriately tested.

Strategic & Operational Contributions

* Support long-range resource planning and budgeting activities.

* Act as a subject matter expert in device technology internally and externally.

Key Relationships

* Internal device development specialists (HF, design, industrialisation, engineering, science)

* Formulation and product development teams

* Quality Assurance & Regulatory teams

* Manufacturing and technical operations teams

Education, Skills & Experience

Required

* Degree, HND, or equivalent in engineering or a technical discipline

* 8–10+ years’ experience in medical device or combination product development

* Demonstrated experience leading multidisciplinary project teams

* Strong knowledge of device design, control, and global regulatory frameworks & Working knowledge of ISO 13485, ISO 14971, ISO 62366, GMP

* Proven experience taking products from concept through commercialisation & Excellent communication and stakeholder management skills

* Practical, analytical and hands-on approach to device development

Preferred

* Experience with injection moulding / Experience with automated assembly or test equipment

* Prior expertise with drug delivery devices or needle-based injection systems
Apply
Location:
Cambridge
Job Type:
FullTime
Category:
Medical/Pharmaceutical/Scientific

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