Job Description
What you need to know Our client who provides innovative products and services to many of the worlds largest medical device and pharmaceutical companies is currently looking to add aDevelopment Engineerto its team in Galway city. As a Development Engineer, you will report directly to the Operations Manager on-site and work collaboratively with them and the engineering team to develop innovative and suitable testing services for leading companies in the medical device and pharmaceutical industries. The role will require someone with a strong technical aptitude who has worked in a regulated manufacturing environment and possesses outstanding project management and interpersonal skills, as well as excellent commercial awareness, as they will frequently interact with key customers. This is apermanent role with an excellent salary and package that includes25 days annual leave, company pension, bonus, life assurance, healthcare and training and development opportunities. Your new job: Duties & responsibilities: You will be responsible for performing specific activities including: develop, modify, verify and validate methods. analysis of results, statements of conformity and opinions/interpretations report, review and authorise results. Manages multiple complex customer testing projects simultaneously. Leads device and packaging testing projects for medical device and pharma customers Interfaces 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. Coordinates staff and schedules equipment resources to execute testing and reporting of results. Designs and documents test jigs and fixtures Working 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. What are we looking for? A degree in engineering, science, or a related field. A 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. Interested in this role? Apply for this job now with a Word version of your CV to Eugene, By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications, we can only reply to applicants suitable for the position. We Value Your Trust Skills: Test Method Validations