Electronical Process Engineer

Electronical Process Engineer

La preghiamo di leggere attentamente i seguenti dettagli prima di inviare la sua candidatura.

As a Process Engineer within BVI Medical’s Capital Equipment Operations team, you will be responsible for supporting the development, transfer, validation, and continuous improvement of manufacturing and testing processes for ophthalmic surgical consoles and related electro‑mechanical medical devices.

In this role, you will work in a dynamic and international environment, collaborating closely with R&D, Technology Transfer, Manufacturing, Quality, Supply Chain, Sourcing, and external technical partners. You will contribute to the industrialisation of new products, support lifecycle management initiatives, and drive process improvements aimed at enhancing quality, efficiency, capacity, and cost‑effectiveness.

This position is ideal for an engineer with strong technical expertise in electronics, electrical systems, or mechatronics, who is passionate about solving complex engineering challenges and supporting the development of innovative medical devices for ophthalmic surgery.

Key Responsibilities

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• Develop, implement, and validate manufacturing and testing processes for ophthalmic surgical consoles and capital equipment.
  
• Support New Product Introduction activities, ensuring a smooth transfer from design and prototyping phases to stable manufacturing processes, ensuring robust, scalable, and compliant processes.
  
• Provide technical support for electro‑mechanical assemblies, electrical wiring, PCBA integration, functional testing, and system‑level troubleshooting.
  
• Collaborate with R&D, Technology Transfer, Manufacturing, Quality, Supply Chain, Sourcing, and other Operations functions to define and execute optimal industrialisation plans.
  
• Act as the voice of Operations within the product development cycle, supporting Design for Manufacturing, Design for Testability, and Design for Excellence reviews.
  
• Define and maintain process documentation, including work instructions, process flows, test methods, validation protocols and reports, PFMEAs, and control plans.
  
• Conduct process studies and data analysis to identify opportunities for improving quality, process robustness, capacity, cycle time, and cost performance.
  
• Lead or support root cause analysis, corrective and preventive actions, and technical investigations related to process or product issues,.
  
• Support the introduction, qualification, and validation of new manufacturing technologies, tools, fixtures, and test equipment.
  
• Ensure manufacturing processes are compliant with applicable quality system requirements and medical device regulations.
  
• Provide training to production operators on new processes and operating procedures, as well as updates to existing procedures.
  
• Interface with internal and external suppliers, manufacturers, and technical partners to support process development, tooling, equipment qualification, prototyping, and production readiness.
  

Qualifications

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• Master’s degree in Electronics Engineering, Mechatronics Engineering, Biomedical Engineering.
  
• Minimum 8 years of relevant experience in process engineering, manufacturing engineering, industrialisation, product development, or a similar technical role.
  
• Strong technical knowledge of electronics, electrical systems, mechatronics, and electro‑mechanical assemblies.
  
• Knowledge of functional testing, system‑level troubleshooting, and integration of electro‑mechanical medical devices.
  
• Experience in process development, validation methodologies (including IQ/OQ/PQ) and continuous improvement within a manufacturing environment.
  
• Good understanding of electrical wiring, PCBA, functional testing, and system‑level integration of electro‑mechanical products.
  
• Strong engineering problem‑solving skills and ability to perform structured root cause analysis.
  
• Excellent analytical skills, with the ability to support data‑driven decisions and process improvements.
  
• Ability to work effectively in cross‑functional and international teams.
  
• Fluent in Italian and English.
  
• Experience in medical devices or other highly regulated industries will be considered a strong plus.
  
• Knowledge of optoelectronics, sensors, lasers, optical fibres, or medical electrical equipment will be considered a plus.
  
• Knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, process validation, lean manufacturing, ECAD, or MCAD tools will be considered a plus. xysqume
  
• Applications from candidates belonging to protected categories under Art 1‑Law 68/99, are welcome and will be positively considered.
  

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