R&D Mechanical Engineer
2 ore fa
PurposeWe 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 advance innovative medical technologies from concept through commercialization, while ensuring compliance with applicable quality and regulatory standards throughout the product lifecycle.Key ResponsibilitiesDesign 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.QualificationBachelor'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.CompanyBVI® 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®, Visitec®, Malosa®, Vitreq®, and PhysIOL®, spanning more than 90 countries.We aim to touch the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye.We empower our associates to solve problems and collaborate, delivering innovative solutions for physicians and patients.#J-*****-Ljbffr
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