Medical Manufacturing Engineer

ICDS Recruitment

Clare

Medical Manufacturing Engineer - County Clare. In this role you will need good problem solving capability, possess a demonstrated capacity to identify problem root causes, deliver solutions, risk assess, create Medical Change Notifications (MCN) documents and co-ordinate with the medical team, vendors and customers for process changes. The successful candidate will display initiative and an ability to lead projects in terms of decision making, innovation, providing schedules, and effective verbal and written communication. As the Business operates on Lean principles such as the elimination of waste and the creation of flow, the successful person must be able to work in Project Teams and use Lean Tools as part of the ongoing Continuous Improvement activities. The successful person must operate to a high standard of compliance to processes and procedures according to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP. Key Responsibilities: Develop machine concepts to resolve quality and productivity issues. Liaise with product designers, production personnel, product managers, quality personnel and all other relevant parties in championing design for manufacturing issues for new machine concepts. Develop and co-ordinate the process FMEA’s for the relevant equipment/process upgrades. Co-ordinate the training function with production departments to ensure the relevant people in the process get the training required to run the processes effectively. Qualify and validate the new process to the agreed qualification criteria and hand over the new process to production. Update machine spares drawings as required and get them live on SAP and Model Manager. Update machine PM systems as required to maximise asset care and machine availability/OEE. New Equipment Introduction: Carry out design reviews on new products. Develop and introduce new equipment solutions and processes - URS, FDS, FAT, SAT, pFMEA. Machine vendor co-ordination and project management. Debug and process qualification (IQ, OQ, PQ. Process Control: Develop process control systems in conjunction with Quality and Production teams, this will ensure the process is sufficient to deliver consistent quality throughout the quality roadmap. Review Process Control Systems - ongoing review of production processes and process control systems, using appropriate inputs (Customer complaint and failure data, in-process failures, efficiency problems, process FMEA etc.) to identify and implement improvement opportunities in the process. Process Improvement: Take on projects designed to improve processes as designated from time to time. This may include the investigation of issues, defects, analysis reports etc. to identify specific problem causes. Work with cross-functional team to deliver on various process improvement plans identified. Carry out process changes according to medical process change procedures, carrying out effective risk assessments and planning efficient implementation of solutions in partnership with the wider Medical Unit, supplier and customer partners. Resolution of Process Problems: Utilise appropriate investigative techniques and analysis to resolve identified process problems as they arise. Liaise with SME’s such as Black Belts and Green Belts to identify problem areas and resolution plans. Follow up and resolve technical problems within the process while complying to medical processes and procedures. Develop ongoing improvement plans with technicians and relevant equipment suppliers and quality team. Other Duties: Provide Training as required in process issues to process/tooling team members. Develop communication processes cross-functionally to ensure process concerns are raised. Provide support in the development and maintenance of the overall process. Develop the capability to bring processes and technology beyond current requirements. Interested applicants should have: At least 5 years' experience. An engineering qualification in a Mechanical discipline to Diploma or Degree level, or other suitable training derived through relevant experience in the mechanical /process field. A strong understanding of statistical principles. Ideally previous experience in the application of Six Sigma principles. Strong organizational, communication and creativity skills. Excellent written and verbal communication skills. Excellent planning and organizational skills and strong interpersonal skills. Experience of ISO 13485 medical quality systems and controls preferred. This job originally appeared on RecruitIreland.com.

2257 days ago