Jobid=a627bc0a84fc (0.0376)
Engineer – Life Cycle Management (LCM)
Industry: Medical Devices
Environment: GMP / ISO Regulated Manufacturing
Location: On-site
Position Summary
We are seeking an Engineer – Life Cycle Management (LCM) to manage product design changes, labeling updates, UDI compliance, and BOM governance within a regulated medical device manufacturing environment.
This role ensures that all lifecycle activities are executed in compliance with GMP, ISO standards, and applicable regulatory requirements while coordinating effectively across R&D, Regulatory Affairs, Manufacturing, and Supply Chain.
Mandatory Requirements
- Bachelor’s or Master’s degree in Engineering
- Minimum 3 years’ experience in a medical device manufacturing environment
- Direct experience with engineering/design change control (ECO/ECN)
- Exposure to regulated medical device labeling processes
- Strong working knowledge of GMP, GDP, and Data Integrity principles
- Experience operating within structured SOP-driven quality systems
- Proven cross-functional coordination experience
- Fluent English (written and spoken)
Key Responsibilities
- Lead and execute design change projects
- Manage product master data and Bills of Materials
- Coordinate labeling changes and ensure regulatory compliance
- Oversee UDI application and maintenance
- Support material phase-in/phase-out activities
- Conduct risk assessments and validation documentation
- Ensure adherence to quality and regulatory standards
If you meet the requirements and would like to be considered, please apply directly or reach out for further details.
Referrals are welcome – if you know a qualified professional with medical device lifecycle and change control experience, feel free to share this opportunity or connect us directly.
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