Senior Mechanical Engineer (R&D)

Physiol; Roma; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading ophthalmic surgical company is seeking a Senior Mechanical Engineer to join their R&D team in Rome. The role involves designing and developing innovative medical device components for surgical use, ensuring compliance with industry standards, and collaborating closely with various teams. Candidates should be fluent in English and Italian, with strong 3D modeling expertise and hands-on experience in mechanical design.

Competenze

• Fluent in English and Italian.
• Experience with rapid prototyping technologies.
• Understanding of ISO, FDA, MDR standards.

Mansioni

• Design and develop medical device components and systems.
• Conduct testing of complex mechanical systems.
• Collaborate with cross-functional project teams.

Conoscenze

Fluency in English

Fluency in Italian

3D modeling software proficiency

Understanding of medical device standards

Knowledge of materials

Hands-on experience with tools

Strumenti

SolidWorks

Creo

Descrizione del lavoro

Job Details : Senior Mechanical Engineer (R&D)

Full details of the job.

Job Requisition Name : Senior Mechanical Engineer (R&D)

Job Requisition No : VN8017

Work Location : Italy - Rome

Worker Basis : Full Time

Worker Type : Employee

Applications Close Date : Jul 31, 2025

Purpose

Responsible for the design and development of mechanical systems and products for ophthalmic surgical devices on the R&D Team.

Key Responsibilities

• Must be able to work onsite at the Rome office.
• Expected local travel required; up to 10% global travel required.
• Design and develop medical device components, sub-assemblies, and complete systems, including associated test and fabrication fixtures.
• Define test methods and conduct testing of complex mechanical systems.
• Interact with internal and external suppliers, manufacturers, and customers.
• Generate detailed part and assembly drawings, applying GD&T techniques, and perform tolerance analysis of complex assemblies.
• Collaborate with project teams (Quality, Regulatory, Manufacturing, and Service) at all development stages and through product lifecycle.
• Support Quality teams in ensuring GxP compliance and activities such as root cause analysis and resolution of complaints.
• Assist Regulatory team with technical documentation as required by authorities.

Qualifications

• Fluent in English and Italian.
• Ability to use fundamental physical laws and quick calculations to assess design challenges.
• Proficiency in 3D modeling software (SolidWorks, Creo preferred) for mechanical design; experience with TDD methodologies is a plus.
• Experience with rapid prototyping materials and technologies for fast iteration.
• Knowledge of materials, manufacturing methods, industry standards, plastic part design, and high-volume production materials.
• Understanding of ISO, FDA, MDR, 13485 standards related to medical device development.
• Hands-on experience with metal-working and assembly tools.

Company

BVI is refocusing the future of vision. As a leading ophthalmic surgical business, our trusted brands include Beaver, Visitec, Malosa, Vitreq, and PhysIOL, spanning over 90 countries. We aim to impact millions of patients worldwide by providing innovative solutions for eye conditions. We foster a culture of collaboration, agility, and transparency, committed to listening to our customers and delivering results. Learn more at .

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