Headcount Engineering is sourcing a Process Engineer for a leading multinational client’s medical device facility. This person will have responsibility for the development and execution of plans to continuously improve and optimize product quality and process yield using designed experiments, problem solving and decision making tools. This role is suited to a natural problem-solver.
· Responsible for identification and implementation of process related continuous improvement activities to improve product quality and increase Overall Equipment Effectiveness (OEE).
· Ensure all process developments and improvements meet the Quality Management System requirements.
· Provide a strong analytical approach to problem solving to deliver innovative solutions.
· Lead and work in cross functional teams.
· Engage with the appropriate personnel in the identification and resolution of Corrective/Preventative actions to address Quality, Technical, and Manufacturing issues (Audit Actions, NCR s, CAPA s, etc).
· Accurate planning, timely delivery and reporting for all project deliverables.
· Participate in risk assessments and HAZOPs of manufacturing processes and equipment.
· Develop and maintain Behavioural Standards in line with company standards and policy.
· Work with team leader to develop and implement strategic engineering Goals & Objectives.
· Primary Degree (Level 8) in Process, Production, Manufacturing, Polymer, Materials, Biomedical or Mechanical engineering with minimum 4 years’ experience. A qualification in Physics is particularly desirable but not a necessity.
· Relevant experience with statistical process control and capability analysis required.
· Achievement of Six Sigma/Green Belt/Black Belt accreditation would be a distinct advantage.
· Excellent analytical and problem solving skills, root cause analysis and risk assessments with a strong attention to detail.
· Familiarity with manufacturing and validation in a regulated (FDA or IMB) environment an advantage.
· Experience of lean concepts such as 5S and standard work would be an advantage.