Functiebeschrijving
About Our Client
Our client is a global leader in the healthcare and medical device industry, dedicated to improving patient outcomes through innovation, quality, and compliance excellence. With a strong international presence and a commitment to advancing medical technologies, the organization operates in a highly regulated environment where collaboration, integrity, and continuous improvement are central to success.
About the Position – Engineer LCM (Life Cycle Management)
For the Leiden site, we are recruiting an Engineer LCM who will play a key role in managing product and component lifecycle activities within a regulated medical device environment.
In this position, you will coordinate design changes, support product registrations and launches, and ensure labeling and documentation updates meet global regulatory and quality standards. You will work closely with cross-functional teams including R&D, Regulatory Affairs, Marketing, Manufacturing, and global stakeholders.
This role is ideal for an engineer who combines technical knowledge with strong project coordination skills and thrives in a structured GMP/ISO environment.
Key Responsibilities
Lead and manage product lifecycle and design change projects from initiation through implementation
Coordinate new material introductions and phase-outs with suppliers and sourcing teams
Drive labeling updates and ensure compliance with regulatory and marketing requirements
Manage Bill of Materials (BOM) updates and collaborate with design and manufacturing teams
Support product registrations and commercial launches across global markets
Oversee Unique Device Identification (UDI) compliance and regulatory requirements
Organize and facilitate cross-functional meetings to align on labeling and design changes
Maintain accurate product master data and lifecycle documentation
Develop and implement validation procedures in line with GMP standards
Analyze data, assess risks, and support continuous process improvements
Ensure full compliance with company policies, GMP, GDP, and data integrity principles
Requirements
Bachelor’s or Master’s degree in Engineering
2+ years of experience in engineering, product lifecycle management, or packaging/labeling within a medical device or regulated manufacturing environment
Strong understanding of design change processes and quality systems (GMP, ISO)
Experience working in cross-functional and international teams
Excellent English communication skills (written and verbal)
Strong project management and organizational skills
Ability to manage multiple priorities and adapt to changing business needs
Proficiency in MS Office tools (Excel, PowerPoint, Word, Project); familiarity with Adobe tools such as InDesign is a plus
Analytical mindset with knowledge of data interpretation and problem-solving
Proactive, collaborative, and quality-driven professional attitude
Ready to Apply?
Don't miss this opportunity! Apply now and join our team.
Functiedetails
Publicatiedatum:
March 1, 2026
Functietype:
Technologie
Locatie:
Netherlands
Company:
SIRE® Life Sciences
Ready to Apply?
Don't miss this opportunity! Apply now and join our team.