Process Engineer

Responsibilities

• Support the implementation of Continuous Improvement activities and develop plans to optimize processes in the manufacturing plant through Lean Manufacturing strategies, tools, and methodologies.
• Support the industrialization team throughout the implementation activities of the product portfolio production (assembly processes, production lines, and workstation layouts).
• Support quality processes, including non-conformity investigations, change management, and validation of manufacturing processes.
• Project management of the process engineering, including coordinating activities to achieve business objectives.
• Verify the product’s manufacturing feasibility by analyzing systems, equipment, and process tools.
• When new investments in machinery and/or technologies are required, support the technical evaluation by identifying the most suitable solution, as well as analyzing the investment and related payback.
• Enter production routings and bills of materials (BOMs) for assigned products into the system.
• Manage technical documentation supporting production, particularly finished product and manufacturing process documentation, production flow charts, risk analysis (P-FMEA), control plans, and work instructions.
• Facilitate the progress of product industrialization through specific procedures and methodologies (DFMA – Design for Manufacturing and Assembly, project management tools).
• Promote solutions aimed at optimizing production processes to improve product quality and/or reduce manufacturing costs.
• Contribute to the validation of new production machinery and any process modifications on existing machines.

Qualifications

• At least two years of experience in a manufacturing environment (preferred above 3 years).
• Intermediate English proficiency (B1 level).
• Master’s Degree in Mechanical Engineering, Mechatronics Engineering, Industrial Engineering, or related fields.
• Solid knowledge of mechanical design and electromechanical systems applied to medical devices and accessories.
• Familiarity with manufacturing technologies for mechanical assemblies, CNC machining, laser engraving, soldering, plastic molding, and pressurized systems.
• Experience with CAD and CAM software.
• Ability to read and interpret mechanical drawings, multilevel bill of material (BOM), technical and safety datasheets.
• Hands‑on experience with mechanical and electrical measurement instruments (calipers, micrometers, multimeters, force/torque gauges).
• Basic knowledge of DFM/DFA principles for injection molded parts, machined components, and cable/harness assemblies.
• Understanding of sterilization impacts on materials and design, cleaning processes, and biocompatibility constraints for accessories.
• Good communication skills; problem‑solving attitude; results‑oriented mindset; ability to work under pressure; strong organizational and observation skills; good listening skills; positive interaction with different departments (R&D, QA, Regulatory Affairs, global stakeholders).
• Basic knowledge of statistics.
• Experience with 3D printing.
• Fiber Optics knowledge.
• Knowledge of Measurement System Analysis (MSA).
• Advanced knowledge of project management tools and methodologies.
• Basic knowledge of ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes.
• Basic knowledge of safety and environmental standards according to ISO 14001 and ISO 45001.