Head of Device Product Development

8 ore fa

parma, emilia romagna, Italia Chiesi Tempo pieno
Overview

In this role, you will lead the Device Product Development department to advance Medical Devices and device constituents in drug-device combos, ensuring feasible design, development, manufacturing and testing within quality and regulatory standards. You will shape strategies from prototyping to product launch, drive innovative device technologies, and manage partnerships with vendors and manufacturing partners. You will influence the project portfolio, resources, and compliance, while developing a high-performance, cross-functional team in a global R&D context. This is a chance to impact how device solutions scale within a patient-focused biopharma environment.

Retribuzione / Benefits
  • pension
  • private medical insurance
  • wellbeing programme
  • flexible benefits programme
  • annual bonus scheme
  • relocation support
Responsabilità
  • Lead and develop the Device Product Development team, ensuring alignment with quality, cGMP, HSE and regulations
  • Identify optimal design, development and manufacturing strategies from prototyping to launch
  • Foster innovative device products and testing technologies aligned with company strategy
  • Participate in due diligences for in-licensing opportunities
  • Support IP strategy and patent development
  • Manage strategic vendor relationships (design agencies, CMOs, test labs, consultants)
  • Ensure successful transfer of device products and specs to Manufacturing or CMOs
  • Prepare and revise SOPs and processes
  • Oversee staff development, capability building and resource allocation
  • Act as centre of excellence for medical devices and combination products balancing internal capacity and outsourcing
  • Contribute to device project portfolio, resources (CAPEX, OPEX, FTE) and management communications
  • Ensure safety and environmental compliance
  • Review and approve Design Controls documentation
  • Provide expertise in medical device quality, risk management, manufacturing and regulatory frameworks (ISO 13485, ISO 14971, cGMP)
Requisiti fondamentali
  • Substantial leadership experience in drug-device combination product development
  • Experience in managing, coaching and developing teams
  • Credibility from progressive leadership roles in comparable settings
  • Proven ability to lead multidisciplinary organizations through growth and transformation
  • Accountability for strategic R&D activities from concept to commercialization
  • Strong scientific and engineering foundation with hands-on industrial experience
  • Ability to operate at the intersection of innovation, quality, regulatory requirements and business objectives
  • Strong interpersonal awareness and trust-building
  • Effective communication and collaboration across diverse teams
  • Fluent in written and spoken English
  • leadership
  • stakeholder management
  • collaboration
  • medical device quality (ISO 13485)
  • risk management (ISO 14971)
  • cGMP