Medical Devices Project Manager

4 settimane fa


Milano, Lombardia, Italia Luminary Group A tempo pieno

Job Title: Medical Devices Project Manager

Job Description:
The Luminary Group is seeking a highly skilled Medical Devices Project Manager to join our team. This role entails analyzing technical documentation and conducting inspections of electromedical products. The successful candidate will contribute to the development of electrical safety and electromagnetic compatibility tests, and be responsible for the effective management of assigned projects.

Key Responsibilities:
• Evaluating technical documentation for electromedical products
• Conducting inspections at client facilities in accordance with ISO 9001/13485, Directive 93/42/EEC, and Regulation 2017/745
• Assisting with the preparation of tenders within their area of expertise
• Compiling reports on inspection activities
• Overseeing the certification processes for client companies
• Providing technical and regulatory support to the laboratory coordinator for testing activities
• Monitoring testing activities related to assigned electromedical devices

Requirements:
• Bachelor's degree in Electronic Engineering, Biomedical Engineering, or a related field
• Familiarity with industry standards and regulations, particularly the IEC 60601 series
• Required experience with electromedical products
• Previous laboratory experience is necessary
• Strong entrepreneurial mindset and organizational skills
• Excellent analytical abilities
• Outstanding interpersonal skills
• Proficiency in English
• Native Italian speaker or fluent

Preferred Qualifications:
• Knowledge of ISO 13485
• Completion of a 40-hour Auditor training course


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