Description

In this role, you will lead device development projects from concept to production, collaborating with cross-functional teams to ensure quality and compliance. Your daily responsibilities will include managing timelines, budgets, and risks while driving innovation and improvement initiatives.

Requirements

• •Bachelor’s degree or equivalent in Product design, Mechanical, Process, Materials Science or Electronic Engineering
• •5+ years of experience in project management
• •10+ years of experience in device development with understanding of device safety and regulatory requirements
• •Deep technical understanding of device design, validation, verification and their link to drug development activities
• •Experience in FDA regulated medical devices and combination drug device products
• •Track record of resolving issues in a matrix organization
• •Strong interpersonal and relationship building skills
• •Solid organizational skills including attention to detail and multi-tasking skills
• •Effective verbal and written communication
• •Fluency in English; additional languages (German or French) are an asset

Tasks

• •Lead cross-functional exercises to define targeted device profiles
• •Develop project plans and budgets with internal and external teams
• •Deliver quality products and processes with proper validation and regulatory documentation
• •Report and control device development timelines, budgets, and risks
• •Act as the main interface between biosimilars project teams and subteams
• •Provide technical and business inputs to projects
• •Analyze risks and suggest mitigation plans
• •Oversee device development, manufacturing, validation, and regulatory activities
• •Proactively identify risk areas and alert stakeholders
• •Report and escalate potential issues to management
• •Identify new device opportunities
• •Lead innovation and continuous improvement projects