17 ott - Como
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
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