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Job Description
Development Engineer
Our client, a leading provider of innovative products and services to the medical device and pharmaceutical industries, is seeking a skilled Development Engineer to join its team in Galway city.
About the Role
- Develop, modify, verify, and validate methods for testing services.
- Manage multiple complex customer testing projects simultaneously.
- Lead device and packaging testing projects for medical device and pharma customers.
- Interface with customers and sales team to assess feasibility and costings of new projects.
- Develop and agree project plans, test protocols, and test methods with customers.
- Coordinate staff and schedules equipment resources to execute testing and reporting of results.
- Design and document test jigs and fixtures.
- Work with the validation team to conduct Test Method Validation studies.
- Assess equipment specifications and suitability for test methods.
- Develop URS for laboratory equipment procurement.
- Support Quality team with investigations, procedure updates, and audits.
- Engage in lean and continuous improvements onsite.
Requirements
- Degree in engineering, science, or a related field.
- Minimum of 3 years experience in a regulated environment in an NPI or R&D Engineer or related role.
- Strong project management skills and a proven ability to deliver numerous projects simultaneously to tight deadlines.
- Strong working knowledge of industry regulatory standards such as ISO 13485, FDA, and EU MDR.
- Excellent knowledge and ability to comply with GMP and GDP best practices.
- Comprehensive knowledge of validations, specifically test method validation.
- Excellent attention to detail and passionate about continuous improvement.
- Ability to interact and influence at all levels within the organisation.
- Strong problem-solving ability.
- Good communicator both verbally and written.
- High level of attention to detail and accuracy.
- Strong organisational and planning skills.
- Ability to work closely with various levels of the organisation to ensure projects are delivered to the highest standards.
- Knowledge of MS Office applications, including Word and Excel.
This is a permanent role with an excellent salary and package that includes 25 days annual leave, company pension, bonus, life assurance, healthcare, and training and development opportunities.