Sr RD Engineer

We are looking for a Engineer Sr, R&D -Administration Sets is responsible of product sustaining and new product design following Design Controls methodology.
Key Responsibilities:
• Research, design, prototype, and develop disposable medical products following strict Design Controls methodology.
• Maintain the highest quality standards adhering to ISO 13485, 21 CFR 820, ANSI, AAMI, and GMP regulations.
• Guide and supervise lower-level engineers and technicians, write and execute validation protocols, own CAPAs, manage ECNs, and serve as project lead. Serve as a Subject Matter Expert (SME) in CAD, CAE, injection molding, and 3D printing.
• Select custom components, collaborate with suppliers, manage project budgets, and evaluate risk, cost, and schedule trade-offs using LEAN / Six-Sigma principles (DFSS / DFM).
Key Requirements:
• Education: Bachelor's degree in Engineering (Mechanical or related discipline). • Professional Experience: 6+ years of relevant experience, with at least 2 years in the medical device industry. • Languages: Fluent in English (B2 CEFR level or higher).