Process Engineer

About the role

The Process Engineer will support manufacturing by developing, validating, and continuously improving processes for new and existing products. The role bridges concept to implementation, ensuring high yield, cost efficiency, and product quality.

Key responsibilities

• Develop and validate manufacturing processes from concept through launch.
• Monitor process performance, yield, cost, and quality, and drive corrective actions.
• Identify root causes of process issues, evaluate data, and implement optimal solutions.
• Lead continuous‑improvement initiatives using Lean tools (6S, VSM, Kaizen, Poka‑yoke, etc.).
• Maintain up‑to‑date GMP‑compliant documentation and support validation activities (protocols, reports).
• Assist with the transfer of new products and automated equipment into production.
• Conduct space‑optimization analysis and maintain equipment layouts.
• Travel minimally (1‑2 weeks per year) as required.

Required profile

• Experience in high‑volume manufacturing process engineering and optimization.
• Proven track record with Lean manufacturing, OEE improvement, risk management, and DMAIC.
• Hands‑on experience installing and transferring automated equipment under medical‑device regulations.
• Strong knowledge of validation protocols (FAT, SAT, IQ‑OQ‑PQ) and process characterization.
• Familiarity with Quality Assurance/Control systems, GAMP, and relevant regulatory requirements.
• Awareness of health‑and‑safety standards (NFPA/OSHA, CE marking).

Required skills

• FAT (Factory Acceptance Test)
• SAT (Site Acceptance Test)
• IQ‑OQ‑PQ (Installation, Operational, Performance Qualification)
• Process characterization
• GAMP (Good Automated Manufacturing Practice)
• NFPA/OSHA compliance
• CE marking requirements

What we offer

• Opportunity to work on cutting‑edge medical‑device manufacturing projects.
• Collaborative environment focused on continuous improvement.
• Professional development and training in validation and Lean methodologies.