Engineer II – Research & Development (Infusion Care)

About the role

We are looking for an Engineer II in Research & Development to lead customer projects, new product development and life‑cycle management of our Infusion Care portfolio. The role is based in Michalovce, Slovakia and offers the opportunity to work on cutting‑edge medical device designs.

Key responsibilities

• Design and develop new products, components and materials following SOPs for Design Control and regulatory requirements.
• Implement changes on existing products using Change Control procedures.
• Author, update, review and approve design‑control and risk‑management documentation.
• Develop and qualify test methods for design verification and process validation.
• Participate in CAPA and non‑conformance investigations, providing technical assessments.
• Lead root‑cause investigations related to product design and drive corrective actions.
• Collaborate globally, communicate technical data and make recommendations based on analysis.
• Generate concepts, 2D/3D models, assemblies and drawings in SolidWorks, applying DFM/DFA principles.
• Maintain compliance with the QMS, health‑safety‑environment standards and stay updated on engineering advances.
• Identify and protect intellectual property.

Required profile

• Proven experience in a mechanical or systems engineering discipline, preferably in medical‑device R&D.
• Ability to manage multiple projects and prioritize workloads across diverse teams.
• Familiarity with ISO 13485, ISO 14971 and FDA 21 CFR 820 requirements.
• Experience with root‑cause analysis, CAPA and design‑control processes.
• Strong communication skills and a collaborative mindset.

Required skills

• SolidWorks (2D/3D modelling, assemblies, drawings)
• Design Control and Risk Management
• ISO 13485
• ISO 14971
• FDA 21 CFR 820
• Root Cause Analysis
• Design Verification & Process Validation
• Design for Manufacturing (DFM) / Design for Assembly (DFA)

What we offer

• Base salary starting at €1 450 per month, dependent on experience.
• Full‑time permanent position on site in Michalovce.
• Opportunities to work on innovative medical‑device projects and develop IP.