Responsabile ricerca e sviluppo

We’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 Responsibilities

• Manage R&D Team resources & activities: Product development; Design Controls; Remediation, Audit Support, VOC, competitor product analysis, literature & patent search
• Provides technical leadership within new product development and sustaining engineering portfolios, and design remediation activities to support company’s EU MDR program
• Provides independent technical review and Subject Matter Expert (SME) during Notified Body/ Competent authorities audits
• Lead R&D Staff, including goal setting, overall team performance & career development
• Collaborate with cross functional management on new initiatives
• Embrace continuous NPD process improvement
• Identify and drive best practices within the R&D group
• Contributes to company Intellectual Property Portfolio
• Effectively communicates activity status, issues and mitigation plans with key stakeholders
• Provides medical and clinical expert opinions regarding products and procedures for risk management documentation and has responsibility for determining acceptable product safety

Qualification

• MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor'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 roles
• 1-3+ years Resource Manager experience, with demonstrated leadership capability to effectively coach, mentor and manage the R&D Team
• Experience working on cross functional project teams in the end-to-end lifecycle bring new products/technologies from concept through commercialization
• Knowledge of applicable materials, manufacturing methods and engineering industry standards and specifications
• Experience operating in regulated design controls environment
• Experience 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, Italy

• OTHER REQUIREMENTS
• Excellent knowledge of spoken and written Italian and English
• May require travel up to 10%.