Lifecycle Management Engineer, Leiden, Zuid-Holland

The Company
A global medical device manufacturer operating in a regulated GMP/ISO environment, focused on product quality, innovation, and continuous improvement across global operations.

Role Description
The Lifecycle Management Engineer manages product and component changes throughout the full lifecycle. The role ensures design changes, labeling updates, documentation, and manufacturing data remain accurate and compliant, while coordinating with global teams to support product launches, process improvements, and regulatory requirements.

Responsibilities
- Manage lifecycle and design change projects to maintain compliance with GMP, SOPs, and regulatory standards.
- Lead labeling updates and coordinate content with global and local stakeholders.
- Maintain and update BOMs, drawings, and product master data.
- Support new material introduction and phase?out with suppliers.
- Coordinate UDI applications and ensure regulatory compliance.
- Analyze data, support validation activities, and contribute to risk assessments.
- Collaborate with engineering, R&D, regulatory, marketing, and manufacturing teams.
- Ensure adherence to documentation, data integrity, and quality systems requirements.
- Perform additional duties as needed.

Requirements
- Bachelor’s or Master’s degree in engineering.
- 2–8 years of experience in medical devices, engineering, or labeling functions.
- Strong English communication skills.
- Experience working with global and cross?functional teams.
- Proficiency in MS Office and project management tools.
- Understanding of GMP, ISO, GDP, and change control processes.
- Strong organizational and problem?solving abilities.
- Experience in manufacturing environments; familiarity with InDesign or Quark is a plus.

Other Information
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