OverviewWe’re seeking an experienced R&D Manager to lead our electromechanical engineering team in Rome, Italy. In this full-time, on-site role, you\'ll manage resources and drive high-impact initiatives across product development, EU MDR compliance, and sustaining engineering. This position blends hands-on engineering & technical leadership with people management, ensuring our devices meet the highest quality and regulatory standards while supporting innovation across the full product lifecycle.Key ResponsibilitiesManage R&D Team resources & activities: Product development; Design Controls; Remediation, Audit Support, VOC, competitor product analysis, literature & patent searchProvide technical leadership within new product development and sustaining engineering portfolios, and design remediation activities to support the company’s EU MDR programProvide 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 groupContribute to company Intellectual Property PortfolioEffectively communicates activity status, issues and mitigation plans with key stakeholdersProvide medical and clinical expert opinions regarding products and procedures for risk management documentation and have responsibility for determining acceptable product safetyQualificationsMINIMUM 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%
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