Pay rate: £33.61-48.02p/h (depending on experience)
Overview
The Device Development Lead will play a key role in the design, development, and lifecycle management of medical devices and combination products (MDCPs). Operating within the Devices Centre of Excellence in Cambridge, the successful candidate will lead cross-functional teams from concept through regulatory approval across global markets.
Responsibilities
* Lead multi-disciplinary device development project teams throughout the full product lifecycle.
* Manage project scope, deliverables, schedules, quality, and costs.
* Oversee design development, concept evaluation, device specifications, verification, and validation.
* Apply design control and risk management principles.
* Collaborate with drug product development, manufacturing, quality, regulatory, and engineering teams.
* Support global regulatory submissions (IND, BLA, NDA, ANDA, MAA, CTD).
* Manage external designers, suppliers, and contract manufacturers.
* Support device investigations, complaints, and change controls.
Qualifications
Education, Skills & Experience
* Degree or HND in engineering or technical discipline.
* 8–10+ years leading device or combination product development teams.
* Strong knowledge of design control, ISO 13485, ISO 14971, ISO 62366, GMP.
* Knowledge of EU MDR, FDA 21 CFR 820
* Experience planning development programs from concept to launch.
* Strong communication and analytical skills.
Preferred:
* Knowledge of injection moulding.
* Experience with automated assembly/testing equipment.
* Experience with FMEA and risk assessment tools.
* Background in mechanical, product, or production engineering.
* Experience developing drug delivery devices or needle injection systems.
* Decisive - Synthesises complex information to determine clear actions.
* Focused - Holds self and others accountable to customer and stakeholder needs.
* Connected - Builds strong internal and external relationships.
* Courageous - Demonstrates integrity through consistent words and actions.
* Resilient - Adapts effectively to shifting priorities and organisational needs.
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