Job Title - Device Project Lead

Location - Cambridge (hybrid work pattern)

Contract - 6 months

Pay - Up to £380 per day via Umbrella

SRG are working with a global leading pharmaceutical company that are seeking a Device Project Lead to join their busy team.

A growing pipeline of medical device and drug/device combination projects. To meet our ambitious future portfolio needs, we are seeking a Device Project Lead in the development of medical and drug delivery devices. By successfully leading the development of the medical devices/combination products, you will help to launch commercially competitive products that will increase access for our patients.

Key responsibilities:

Project leadership (planning, co-ordination, specifications, risk management, documentation, design transfer etc.)
Development oversight (market research; user research; concept generation, development and analysis; detail design (e.g. including 3D CAD and engineering drawings); ergonomics and usability (including HF/UE documentation); design reviews).
creation and management of Design History Files and associated documentation for selected combination products in accordance with the annual plan and objectives, and relevant standards and guidances e.g. ISO13485, 21 CFR Part 820.30, 21 CFR 3.2(e).
Lead, represent, and manage cross-functional device project teams.
Management of activities in accordance with project strategies, budget, timelines, regulatory, quality, and professional standards.
Enabling operational excellence in compliance with the current and anticipated professional trends.
Performing activities in compliance with Good Manufacturing Practice
Ensuring inspection readiness

Basic Qualifications:

University degree in relevant subject (mechanical engineering, product design, physics etc.) or other equivalent degree.
Knowledge of GMP and international device regulations.
Ability to communicate and collaborate effectively in a highly international and diverse setting
Track record of goal-driven behaviour, problem solving, ability to make pragmatic decisions, readiness for new challenges
Work experience in medical devices/combination product development.
Knowledge of regulatory/QA requirements for medical devices/combination products; and
Digital excellence and automation of documentation

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy