Job Details: Senior Mechanical Engineer (R&D)Full details of the job.Job Requisition Name: Senior Mechanical Engineer (R&D)Job Requisition No: VN8017Work Location Name: Italy - RomeWorker Basis: Full TimeWorker Type: EmployeeApplications Close Date: Jul 05, 2024Purpose: 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 as well as associated test and fabrication fixtures.Define test methods and conduct testing of complex mechanical systems.Interface with internal and external suppliers, manufacturers, and customers.Generate detailed part and assembly drawings while applying GD&T techniques and perform tolerance analysis of complex assemblies.Work collaboratively with project teams (e.g., Quality, Regulatory, Manufacturing, and Service) at all stages of development and through product lifecycle.Support of Quality teams in ensuring GxP and other activities (e.g., complaints root causing and resolution).Support of Regulatory team with technical documentation as mandated by authorities.Qualifications:Ability to use knowledge of fundamental physical laws and quick back-of-the-envelope calculations to quickly assess design challenges.High level of proficiency in 3D modeling software (Solidworks, and/or Creo preferred) for mechanical design.
Experience with TDD methodologies.Experience leveraging rapid prototyping materials and technologies for fast prototype build and design iteration.Knowledge of applicable materials, manufacturing methods and engineering industry standards and specifications.Knowledge of plastic part design and materials for high volume part production.Knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices (e.g., FDA, MDR, 13485 etc.
).Effectively utilize problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities.Excellent interpersonal and communication skills with all levels of associates, management and external partners.Hands-on experience with common metal-working and assembly tools.MINIMUM REQUIRED EDUCATION AND EXPERIENCE:Bachelor's degree in engineering or equivalent years of directly related experience.Medical Device Experience preferred.Fluent English and Italian.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 #J-18808-Ljbffr