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R&D Mechanical Engineer
4 ore fa
Purpose
We are seeking an experienced Mechanical Engineer to support the design and development of accessories for ophthalmic surgical devices. This full-time, on-site role based in Rome, Italy, will play a key part in advancing innovative medical technologies from concept through commercialization, while ensuring compliance with applicable quality and regulatory standards throughout the product lifecycle.
Key Responsibilities
- Design and develop accessories and components for ophthalmic surgical devices, from concept through verification, validation, and production transfer.
- Lead the development and evaluation of prototypes, including associated test methods, fixtures, and fabrication tools.
- Generate detailed part and assembly drawings, applying GD&T principles and performing tolerance analysis to ensure robust and manufacturable designs.
- Define, execute, and document test methods to verify design performance and compliance with specifications.
- Interface with internal and external suppliers, manufacturers, and development partners to support design, prototyping, and production activities.
- Collaborate cross-functionally with Quality, Regulatory, Manufacturing, Procurement, Purchasing, and Service teams throughout all stages of development and sustaining activities.
- Support Quality activities in compliance with GxP and related processes, including complaint investigation, root cause analysis, and corrective actions.
- Support Regulatory activities by preparing and contributing to technical documentation required by regulatory authorities, including validation protocols, reports, specifications, and execution of validation activities.
- Organize and conduct investigatory testing as required to support design decisions, risk management, and product improvements.
- Contribute to continuous improvement of design and development processes.
Qualification
- Bachelor's degree in Mechanical Engineering, Materials Engineering, or a related field; advanced degree preferred.
- Minimum 5 years of experience in the medical device industry or equivalent regulated product development experience.
- Experience working within a regulated design controls environment (e.g., EU MDR, FDA, ISO
- Strong knowledge of materials, manufacturing methods, and engineering standards.
- Experience with plastic part design for high-volume manufacturing and rapid prototyping technologies.
- Knowledge of optoelectronics (optical fibers, lasers, sensors) is a plus.
- Strong communication skills, proactive mindset, and ability to deliver against project deadlines.
- Excellent written and spoken Italian and English.
- Must be able to work on-site in Rome, Italy; up to 10% travel may be required.
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.
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