Configuration Control Engineer.

Are you passionate about engineering processes, product lifecycle management, and regulatory compliance? We are looking for a Configuration Control Engineer to join our team and play a key role in managing product configuration throughout its lifecycle, ensuring consistency, traceability, and compliance within a regulated medical device environment.

Manage and maintain item masters, Bills of Materials (BOMs), engineering drawings, and technical specifications.

Ensure consistency and traceability across product configurations, documentation, and physical components.

Develop and implement configuration management policies and procedures in accordance with applicable standards and company requirements.

Lead and manage Engineering Change Orders (ECOs) and Engineering Change Notices (ECNs).

Coordinate cross-functional activities between Engineering, Quality, Purchasing, and Manufacturing teams.

Track, monitor, and ensure timely implementation of approved changes across systems and production processes.

Maintain and manage product data within PLM and ERP systems.

Ensure data accuracy, integrity, and compliance across all product-related records.

Ensure compliance with ISO 13485 and other relevant quality and regulatory standards.

Prepare documentation and support internal and external audits.

Provide guidance and support on configuration management and change control processes.

Train employees on configuration management procedures and best practices.

Bachelor's degree or Practical Engineering degree in Industrial Engineering, Mechanical Engineering, or a related field.

Minimum of 3 years of experience in Configuration Control/Configuration Management within a manufacturing environment.

Experience in the medical device industry – a significant advantage.

Strong knowledge of ISO 13485 requirements.

Hands-on experience with PLM and ERP systems (Agile and Priority preferred).

Familiarity with SolidWorks and ePDM.

Excellent English communication skills (written and verbal).

Ability to work effectively in a multidisciplinary, cross-functional environment.

Strong organizational and documentation skills.

Process-oriented mindset with excellent attention to detail.

Analytical thinking and problem-solving abilities.

Excellent interpersonal and communication skills.

Ability to manage multiple priorities and stakeholders simultaneously.

Join an innovative medical device company where your expertise will directly contribute to maintaining product quality, compliance, and operational excellence while supporting the development of life-changing technologies.

Interested candidates are invited to apply and become part of a team dedicated to innovation, quality, and improving patient outcomes.

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