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.