Device Project Lead

Device Project Lead

Sandoz

Cambridge, United Kingdom

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Experience with combination products (or device constituent parts thereof) and standalone medical devices
• Project leadership (planning, co-ordination, specifications, risk management, documentation, design transfer etc.); and Development oversight including; detail design; ergonomics and usability (including HF/UE documentation); lead 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). etc.;
• 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.

What you’ll bring to the role:

Essential Requirements:

• University degree in relevant subject (mechanical engineering, product design, physics etc.) or other equivalent degree with 5+ years of experience
• 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 behavior, problem solving, ability to make pragmatic decisions, readiness for new challenges
• Fluency in English