R&D Engineer Ii
PROCHEM Engineering Limited
Wexford
Role Summary: Primary focus of this position is to support in developing, optimizing, implementing, and validating components/elements of a medical device. The candidate will perform hands-on testing in optimization of a device; conduct process development activities to understand process inputs and outputs; assist/write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support equipment development; support other activities from R&D, Quality, Operations, and Regulatory Affairs. Core Duties and Responsibilities: Ensure quality of process and product as defined in the appropriate operation and material Initiates new or revised documentation and tracks through appropriate approval cycles and implementation. Maintains a professional working relationship with internal and external customers. Design components of a medical device, translating intangible design inputs into tangible engineering specifications and drawings. Select appropriate materials, processes and vendors to achieve the design, and challenge these designs against design specifications, clinical use scenarios and international standards. Build test parts for engineering evaluation, pre-clinical studies and clinical studies. Process Development: assists in the development and optimization of processes to understand key process inputs and outputs, using statistic methods such as DOE as appropriate. Supports new process equipment and tooling development, including specification development, vendor selection and negotiation. Documentation: prepare work instructions and standard operating procedures (SOP), write technical documents and reports. Prepare raw material specifications and drawings. Assist in preparing verification and validation protocols and reports. Test Method Development: develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods. Testing: perform lab bench testing, conduct engineering and competitor evaluations, development unit testing, and execute verification and validation activities. Training: train technicians on new design and process development as well as new test methods. Assist/conduct new process development training with operations and quality assurance. Supervisory/mentoring/coaching: Mentor/coach R&D technicians through New Product Development. activities like new process development, R&D materials/inventory control etc. May lead or manage technicians or engineering interns. Other Responsibilities may include, however are not limited to: Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines. Assist in design and process root cause analysis and support non-conforming product and complaint investigations. Minimum Qualifications and Experience: B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline, or equivalent experience. To Apply: If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us: 14 Danville Business Park, Kilkenny, Ireland. +353 56 77 90100. recruitment@prochem.ie. Click here to submit your CV Please note, we do not require agency assistance with this role. .
919 days ago