Device Industrial Development Senior Specialist

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, c

GMP)

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)