Purpose Manage R&D resources to support high impact Research & Development initiatives, including EU MDR, sustaining, and product development.Key ResponsibilitiesManage R&D Team resources & activities: Product development; Design Controls; Remediation, Audit Support, VOC, competitor product analysis, literature & patent searchProvides technical leadership within new product development and sustaining engineering portfolios, and design remediation activities to support BVI’s EU MDR programProvides independent technical review and Subject Matter Expert (SME) during Notified Body/ Competent authorities auditsLead R&D Staff, including goal setting, overall team performance & career developmentCollaborate with cross functional management on new initiativesEmbrace continuous NPD process improvementIdentify and drive best practices within the R&D groupContributes to company Intellectual Property PortfolioEffectively communicates activity status, issues and mitigation plans with key stakeholdersProvides medical and clinical expert opinions regarding products and procedures for risk management documentation and has responsibility for determining acceptable product safetyOther duties as required Qualification MINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor's degree in Mechanical or Biomedical Engineering, or related field, Advanced Degree or MBA preferred.10 years’ relevant experience in the medical device industry; or equivalent combination of education, training and experience, with related project management experience and/or team leadership roles1-3+ years Resource Manager experience, with demonstrated leadership capability to effectively coach, mentor and manage the R&D TeamExperience working on cross functional project teams in the end-to-end lifecycle bring new products/technologies from concept through commercializationKnowledge of applicable materials, manufacturing methods and engineering industry standards and specificationsExperience operating in regulated design controls environmentExperience operating in regulated design controls environment with knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices (e.g., FDA, MDR, 13485 etc.)Must work onsite in Rome, ItalyOTHER REQUIREMENTSExcellent knowledge of spoken and written Italian and EnglishMay require travel up to 10%. CompanyAs 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.