Device Development Lead

SRG; Cambridgeshire and Peterborough; On-site; GBP 46,301 - 66,152; Full time

Job summary

A leading medical devices company is looking for a Device Development Lead to guide the design and lifecycle management of medical devices. In this role, you will lead cross-functional teams from concept to regulatory approval and ensure compliance with design control and regulatory standards. Ideal candidates will have 8-10+ years of experience in device development and a degree in engineering or a related field. Strong communication and analytical skills are essential.

Qualifications

• 8–10+ years leading device or combination product development teams.
• Knowledge of ISO 13485, ISO 14971, ISO 62366, GMP.
• Knowledge of EU MDR, FDA 21 CFR 820.

Responsibilities

• Lead multi-disciplinary device development project teams throughout the full product lifecycle.
• Manage project scope, deliverables, schedules, quality, and costs.
• Support global regulatory submissions (IND, BLA, NDA, ANDA, MAA, CTD).

Skills

Strong knowledge of design control

Strong communication skills

Analytical skills

Education

Degree or HND in engineering or technical discipline

Job description

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.