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This employer is Galway based well established medical devices company designing, developing and manufacturing balloon and stent catheters and sells primarily to the Japanese market. They have subsidiaries in Japan, Ireland and USA.
About Your New Job as a Validation Engineer
* Design, scheduling and execute test method validations from incoming inspection, in-process and finished product inspection associated with PTCA catheter products.
* 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.
* Support other validation activities with subject matter expertise and guidance, reviewing external testing partners methodologies, protocols and reports for compliance with relevant regulatory requirements.
* Working as part of a cross-functional project team, responsible for the site test method validation related activities
* Estimation of validation timelines & resource requirements
* Generate and approve standard operating procedures for test method validation
* Ensuring compliance of test method validation process with ISO, PMDA, 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)
* Co-ordinate and execute validation activities
* Provision of 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
What Skills You Need to succeed as a Validation Engineer
* A minimum of 5-8 years working in a relevant medical device manufacturing environment
* Relevant third level qualification in science or engineering (Level 8)
* Knowledge of medical device manufacturing from a validation, regulatory, or testing perspective
* Practical experience and good working knowledge of test methods relevant to; catheter-based delivery devices, preferably PTCA balloon catheters
* Knowledge of the regulatory framework around medical device validation requirements
* 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 organisation and interaction with customers
* Excellent analytical, numerical, problem solving skills and attention to detail
What’s on Offer for Candidates for a Validation Engineer:
* Salary of 85k
* Attractive benefits package - pension, healthcare with dental, paid maternity & paternity, discount scheme and more.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
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