Senior R&D Engineer – Administration Sets

About the role

We are seeking a Senior R&D Engineer specialized in administration sets to lead product sustaining and new product design within a regulated medical device environment. The role combines hands‑on development, validation, and project leadership while ensuring compliance with strict design control standards.

Key responsibilities

• Research, design, prototype, and develop disposable medical products following Design Controls methodology.
• Maintain compliance with ISO 13485, 21 CFR 820, ANSI, AAMI, and GMP regulations.
• Guide and supervise junior engineers and technicians, write and execute validation protocols, own CAPAs, manage ECNs, and act as project lead.
• Serve as Subject Matter Expert 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 and Six‑Sigma principles (DFSS/DFM).

Required profile

• Bachelor’s degree in Mechanical Engineering or a related discipline.
• Minimum 6 years of relevant experience, including at least 2 years in the medical device industry.
• Fluent English (B2 CEFR level or higher).

Required skills

• CAD
• CAE
• Injection molding
• 3D printing
• Lean methodology
• Six‑Sigma (DFSS, DFM)