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 guidance 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.
* Digital excellence and automation of documentation.