19 ott - Egna
Chiesi
Overview
In this role, you will lead the industrialization, validation and lifecycle management of Device Constituent Parts and device platforms, ensuring scalable, compliant development and technology transfer. You will drive cross-functional alignment across R&D;, Quality, Regulatory, Manufacturing, and external partners to secure regulatory compliance and business continuity. You will oversee validation plans, change management and risk assessment to improve device robustness and manufacturing reliability. This position offers the opportunity to shape end-to-end device lifecycle within a global supply framework and contribute to a sustainable, high-quality product pipeline.
Retribuzione / Benefits
annual premio
comprehensive benefits package
company pension
private medical insurance
relocation support
remote work options
Responsabilità
Lead industrialization and scale-up projects for Device Constituent Parts (DCPs) across development, validation and technology transfer
Provide technical leadership for validation, change management, risk assessment,
and industrial development across device platforms
Coordinate cross-functional projects involving R&D;, Quality, Regulatory Affairs, Engineering, Manufacturing Sites, and CMOs
Prepare, execute and review validation plans, protocols, reports, and development studies supporting lifecycle initiatives
Support investigations, root cause analyses and corrective actions to ensure product robustness and business continuity
Assess and implement changes affecting Device Constituent Parts
Collaborate with sites and partners to align on technical strategies, process improvements, scale-up and lifecycle management
Contribute to technical documentation for regulatory submissions and compliance with Medical Device Regulation
Requisiti fondamentali
8-10 years in industrialization, validation, and lifecycle management of medical devices and/or drug-device combination products
Strong engineering background with hands-on product development
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PRODUZIONI
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