Device Industrial Development Senior Specialist
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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 bonus
- 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 and manufacturing experience
- Proven experience leading cross-functional technical projects
- Solid understanding of regulated environments, validation practices, change management and Medical Device Regulation requirements
- Experience supporting industrialization, scale-up, technology transfer and process improvements across multiple sites and CMOs
- Ability to translate technical data into actionable recommendations for multidisciplinary teams
- Effective stakeholder management and communication skills
- Strong analytical and problem-solving capabilities including investigations and root cause analysis
- Ability to balance technical, quality, regulatory, timeline and business considerations in complex projects
- Collaborative mindset for matrix organizations and external influence
- Expertise in medical device quality, risk management, manufacturing and regulatory frameworks (ISO 13485, ISO 14971, cGMP)
- Fluent in written and spoken English
- stakeholder management
- communication
- problem-solving
- medical device quality systems
- risk management (ISO 14971)
- regulatory frameworks (ISO 13485, regulatory submissions)
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