Engineer LCM

LCM Engineer
Location: Leiden, The Netherlands


About the Role
We are seeking an LCM Engineer to support and lead product lifecycle activities within a highly regulated medical device manufacturing environment.
In this role, you will be responsible for managing product and component design changes, ensuring compliance with global regulatory standards, and supporting new product introductions and commercial launches.
You will collaborate closely with Engineering, R&D, Regulatory Affairs, Quality, Procurement, Labeling, and Global LCM teams to ensure that product updates, documentation, and market?related changes are executed accurately, efficiently, and in line with GMP/ISO expectations. Key Responsibilities
Product Lifecycle & Change Management

• Lead design change projects ranging from low to high complexity, ensuring all changes follow the correct quality processes.
• Manage lifecycle updates for products, components, and materials, including new material introduction and phase?out.
• Support new product registrations, global submissions, and commercial launch activities.
• Maintain and update product master data, BOMs, drawings, labeling content, and related documentation.

Labeling Ownership

• Lead labeling design and update projects, ensuring compliance with regulatory and marketing requirements.
• Act as the primary representative of the Labeling Center of Excellence (CoE) and main contact for questions or escalations.
• Coordinate cross?functional labeling content discussions and approvals.
• Manage Unique Device Identification (UDI) activities and ensure compliance with all local/global regulations.

Cross?Functional Project Leadership

• Lead and coordinate multifunctional teams to deliver process improvements, cost reductions, quality enhancements, and lifecycle projects.
• Organize review meetings, risk assessments, and mitigation activities.
• Collaborate with suppliers and sourcing teams for component changes or material transitions.

Compliance, Quality & Documentation

• Ensure projects meet safety, GMP, and ISO requirements.
• Prepare, write, and implement validation procedures as needed.
• Review and analyze data using statistical methods to identify abnormal trends and root causes.
• Apply strong understanding of GMP fundamentals, Data Integrity (DI), and Good Documentation Practices (GDP).

General Responsibilities

• Ensure timely communication of issues or opportunities to management.
• Maintain compliance with all company, local, national, and international regulations.
• Support continuous improvement initiatives within the department.
• Perform other duties as assigned.

Required Qualifications

• Bachelor’s or Master’s degree in an engineering discipline.
• Experience level may vary depending on final seniority (2–3 years for junior/mid, 3–5 or 6–8 for full senior).
• Experience in engineering, product lifecycle, or labeling within a medical device or highly regulated manufacturing environment.
• Strong knowledge of GMP and quality processes.
• Experience working with cross?functional teams across multiple time zones.
• Excellent written and verbal communication skills in English.
• Strong project management and organizational capabilities.
• Able to handle multiple priorities and shifting needs in a fast?paced environment.

Preferred Qualifications

• Experience with Adobe design tools for labeling (InDesign, Quark) is a plus.
• Familiarity with medical device regulations and documentation standards.
• Experience in manufacturing environments and developing/maintaining BOMs.
• Background in short? and long?term project planning.