Device Industrial Development Senior Specialist

This is what you will do

Ensure the successful delivery of DCP/Device lifecycle management, scale-up and industrialisation activities by providing technical leadership, project governance and oversight of validation, change implementation and risk management processes. Drive alignment across internal functions, external partners and manufacturing sites to secure compliance and business continuity.

You will be responsible for

• Lead industrialization and scale-up projects for Device Constituent Parts (DCPs), coordinating cross-functional activities and ensuring the successful execution of development, validation, and technology transfer activities.
• Provide technical leadership for validation, change management, risk assessment, and industrial development activities across device platforms.
• Manage and coordinate cross-functional projects involving R&D, Quality, Regulatory Affairs, Engineering, Manufacturing Sites, and CMOs.
• Drive the preparation, execution, and review of validation plans, technical protocols, reports, and development studies supporting industrialization and lifecycle management initiatives.
• Support problem-solving investigations, root cause analyses, and the implementation of corrective actions to ensure product robustness and business continuity.
• Oversee the assessment and implementation of changes affecting Device Constituent Parts.
• Collaborate with manufacturing sites and external partners to ensure alignment on technical strategies, process improvements, scale-up activities, and lifecycle management initiatives.
• Contribute to the preparation of technical documentation required to support regulatory submissions and compliance with Medical Device Regulation requirements.
• Monitor project risks, timelines, and deliverables, providing technical guidance and governance to support successful project execution.
• Promote continuous improvement initiatives aimed at enhancing device robustness, manufacturing reliability, supply continuity, and operational excellence.

You will need to have

• 8 -10 years in the industrialization, validation, and lifecycle management of medical devices and/or drug-device combination products.
• Strong engineering background and technical expertise combined with hands-on experience in product development, industrialization, and manufacturing.
• Proven experience in leading cross-functional technical projects involving Quality, Engineering, Manufacturing Sites, and external partners.
• Strong understanding of regulated environments, including validation practices, change management, risk assessment, and Medical Device Regulation requirements.
• Demonstrated ability to support industrialization, scale-up, technology transfer, and process improvement activities across multiple manufacturing sites and CMOs.
• Ability to translate technical data into sound recommendations and support decision-making across multidisciplinary teams.
• Effective stakeholder management and communication skills, with the ability to build constructive relationships across functions and external partners.
• Strong analytical and problem-solving capabilities, including experience in investigations, root cause analysis, and implementation of corrective actions.
• Ability to balance technical, quality, regulatory, timeline, and business considerations when managing complex projects and changes.
• A collaborative mindset, with the ability to work effectively in matrix organizations and influence outcomes.
• Expertise in medical device quality, risk management, manufacturing, and regulatory frameworks, including ISO 13485, ISO 14971, cGMP, and related global regulatory requirements.
• Fluent in written and spoken English.

Location

The role is based in Parma. Remote working is possible with regular presence in Parma

Availability for regular travel to manufacturing sites and external partners.

Budgeted Salary Range