Your responsibilities

• We are seeking a PLM Process Excellence Manager to lead the optimization, standardization, and future automation of our Product Lifecycle Management (PLM) processes. This role is pivotal in ensuring cross-functional alignment and driving continuous improvement across the product lifecycle:
• Drive process optimization, standardization, and automation initiatives across the product lifecycle
• Ensure alignment with Quality, Regulatory, R&D, Manufacturing, Supply Chain, and Commercial
• Identify, design, and implement continuous improvement initiatives using Lean, Six Sigma and Kaizen methodologies
• Ensure PLM processes comply with global regulatory standards (e.g., FDA, MDR, ISO 13485)
• Support implementation and enhancement of PLM platforms and systems
• Act as a change agent, training and supporting stakeholders on process changes and best practices
• Develop and maintain process documentation, KPIs, dashboards and training materials
• Collaborate with global cross-functional teams to ensure consistent process execution and governance

Your qualifications

• Bachelor's or Master’s degree in Engineering, Life Sciences Business, or related field
• Proven experience in PLM process management and improvement in a regulated environment or medical devices
• Strong knowledge of regulatory standards (FDA, MDR, ISO 13485)
• Certification in Lean, Six Sigma, or similar methodologies is a plus
• Fluent in English and German
• Familiarity with adjacent systems such as ERP, QMS, eDMS
• Excellent communication and stakeholder management skills
• Ability to work independently and striving for practical solutions

What we offer

About Medartis