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%.