Working as part of the equipment group, the engineer will be accountable for the introduction of automated equipment used in our manufacturing and new technologies process. Working from proof of concept development through to achieving production KPI’s – generating all relevant documentation, including validations. Ongoing support of existing processes in including equipment failure mode reduction on legacy equipment. The role will require a strong proven track record in validations.
• Introduce manufacturing processes to meet the demands of a medical devises business
• Be part of the design team on new production equipment
• Lead the manufacturing engineering function of equipment introduction including engineering trials, reports, validation documentation generation from IQ to PQ
• Production of support documentation including BOMs, manuals etc.
• On-going support of existing processes, identify and put in place permanent and effective technical / system solutions to problems.
• Maintain high quality / compliance standards in line with Medical Devices manufacturing requirements
• Ensure goals and objectives are met and understood by effective communication, building an atmosphere of openness, honesty and flexibility with individuals and within the team environment.
• Manage external relationships with Technology providers / Suppliers.
• Ensure that all Health, Safety and Environmental requirements are fulfilled Researching solutions to existing process problems
• Technical support to production
• Engineering degree, or equivalent qualification, preferably with 5 to 7yrs experience.
• Strong technical background and capabilities.
• Demonstrated data analytics driven problem solving ability
• Motivated to work on own initiative and the ability to make and implement decisions.
• Knowledge of ISO and FDA compliance with emphasis on validation.
• Excellent communication, planning and organisational skills.
• A demonstrated ability to solve problems with innovative and cost effective solutions.
• Excellent working knowledge of equipment and process validation
• Strong hands on equipment background