Senior Validation Engineer (23-month contract role.)
We are seeking a skilled Validation Engineer to design, document, and release Test Method Validation Operating Procedures. This role involves training and supporting these procedures through adoption and maturity, ensuring compliance with ISO, PMDA, and FDA requirements related to the manufacture of PTCA catheter products. The engineer will design, schedule, and execute test method validations for incoming inspection, in-process, and finished product inspections. Additionally, the engineer will provide early-stage consultation to other departments on test method requirements at project proposal stages and support other departments in designing, documenting, performing, and improving test methods and inspection procedures. The role requires using relevant statistical bases to demonstrate the accuracy, precision, and reliability of test methods and participating in the development of new test methods. The engineer will also support other validation activities with subject matter expertise and guidance, reviewing external testing partners' methodologies, protocols, and reports for compliance with relevant regulatory requirements.
Role & Responsibilities:
Work as part of a cross-functional project team, responsible for site test method validation activities.
Estimate validation timelines and resource requirements.
Generate and approve standard operating procedures for test method validation.
Ensure compliance of test method validation processes with ISO, PMDA, and FDA regulatory requirements.
Generate and approve test methods Master Validation Plan & Report.
Generate and approve test method validation protocols and reports.
Actively involve in the development of risk assessments (FMEA).
Coordinate and execute validation activities.
Provide project progress updates to the Site Validation Lead.
Escalate validation-related issues and risks in a timely manner.
Perform statistical analysis of validation results for comparison to acceptance criteria.
Train and mentor team members on validation processes and procedures.
Education Requirements:
Minimum of 5-8 years working in a relevant medical device manufacturing environment.
Practical experience and good working knowledge of test methods relevant to catheter-based delivery devices, preferably PTCA balloon catheters.
Relevant third-level qualification in Science or Engineering (Level 8).
Knowledge of medical device manufacturing from a validation, regulatory, or testing perspective.
Excellent analytical and problem-solving skills.
Excellent numerical skills and attention to detail.
Proven ability to work as part of a multi-disciplinary team in a dynamic environment.
Proven track record of committing to and meeting deadlines.
Effective communicator with all levels of the organization and interaction with customers.
Knowledge of the regulatory framework around medical device validation requirements.
For a confidential discussion and more information on the role, please contact Davin Ferguson.
davin.ferguson@collinsmcnicholas.ie
071-9140251