[ref. u38628604] Test Method Validation Engineer

We are seeking a highly driven Test Method Validation Engineer to join our client's medical device manufacturing team on a 12-month contractual basis. This role focuses on the validation of test systems and manufacturing processes to meet stringent industry standards and internal quality protocols.

Key Duties and Responsibilities:

• Design, plan, and execute validations of test methodologies used in production and quality assurance, ensuring alignment with regulatory frameworks and company procedures.
• Lead process validation efforts for medical device manufacturing operations, driving compliance and quality.
• Determine the necessary criteria and documentation for installing new testing fixtures and production tools.
• Conduct thorough analysis of processes, defining key performance parameters and acceptable output criteria.
• Compile comprehensive validation protocols and reports that adhere to industry and organizational requirements.
• Perform verification testing to confirm process consistency and reliability.
• Contribute to cross-functional project planning and ensure timely execution of validation activities.
• Maintain meticulous documentation and data records, ensuring audit-readiness.
• Apply critical thinking to identify and resolve technical issues effectively.
• Work independently across multiple ongoing tasks, demonstrating flexibility and self-direction.
• Actively pursue opportunities for professional growth and continuous improvement.
• Support or represent senior engineering leadership in their absence, including the Test Engineering and Manufacturing Management functions.
• Conduct all business in line with the organization's ethical standards and compliance codes.

Candidate Profile:

• A degree in Engineering or a related scientific/technical field is preferred, though equivalent practical experience will be considered.
• At least five years of hands-on experience in validation within a regulated industry, ideally medical devices.
• Strong ability to manage projects and meet deadlines in a high-pressure environment.
• Excellent communication and collaboration skills, with the capacity to engage effectively across teams and management levels.
• Strong organizational capabilities and attention to detail.
• Proven aptitude for troubleshooting and process improvement.
• Enthusiastic team player with a proactive mindset and a passion for delivering quality results.
• Committed to personal development and maintaining all required job-related certifications or training.