Electronical Process Engineer

BVI Medical; Roma; In loco; EUR 40.000 - 45.000; Tempo pieno

Descrizione del lavoro

BVI Medical is seeking a Process Engineer to support development, transfer, validation and continuous improvement of manufacturing and testing processes for ophthalmic surgical consoles and related electro‑mechanical devices.

The role focuses on industrialization, lifecycle management, and driving improvements in quality, efficiency, capacity, and cost, within a dynamic international team. Fluency in Italian and English is required.

Competenze

• Master's degree in electronics/ mechatronics/biomedical engineering.
• 8+ years in process/manufacturing engineering or similar.
• Experience with IQ/OQ/PQ and validation in manufacturing.
• Strong knowledge of electronics, electrical systems and electro‑mechanical assemblies.
• Fluent in Italian and English.

Mansioni

• Develop, validate, and improve manufacturing and testing processes for ophthalmic consoles and capital equipment.
• Support New Product Introduction to transfer designs into mature, compliant processes.
• Provide technical support for electro‑mechanical assemblies, wiring, PCBA integration and testing.
• Collaborate cross-functionally to define industrialization plans and ensure design-for-manufacturing alignment.
• Lead root-cause analyses and CAPA activities for process or product issues.
• Establish and maintain process documentation, control plans and PFMEAs.
• Train operators on new processes and updates to procedures.
• Interface with suppliers and external partners for prototyping and production readiness.

Conoscenze

Electronics

Mechatronics

Electrical systems

Process optimization

Data analysis

Root cause analysis

Cross-functional teamwork

English

Italian

Formazione

Master's in Electronics Engineering

Master's in Mechatronics Engineering

Master's in Biomedical Engineering

Strumenti

ECAD tools

MCAD tools

PCBA integration

Descrizione del lavoro

Purpose

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 industrialization 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

• 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 industrialization 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.

Qualification

• Master’s degree in Electronics Engineering, Mechatronics Engineering, Biomedical Engineering.
• Minimum 8 years of relevant experience in process engineering, manufacturing engineering, industrialization, 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 fibers, 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.
• Applications from candidates belonging to protected categories under Art 1- Law 68/99 are welcome and will be positively considered.

Offered Salary Range: €40,000–€45,000

CCNL: Metalmeccanico Industria

Company

BVI® is refocusing the future of vision. As one of the fastest‑growing, diversified surgical ophthalmic businesses in the world, our purpose‑built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single‑Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com