Aurora Lifesciences long standing client now as has a requirement for a Senior Manufacturing Engineering. The Senior Manufacturing Engineer will lead manufacturing and process development engineering activities associated with the medical device manufacture. They will contribute to the product life cycle and the development of new or the optimization of existing manufacturing processes.
Job Responsibilities:
• Analysis of manufacturing KPI’s and the development of continuous improvement projects to drive throughput and yield improvements.
• Partner with Manufacturing, Quality and R&D Engineers across global sites to develop and validate critical processes.
• Undertake root cause analysis to identify opportunities to optimise/improve manufacturing processes including using continuous improvement engineering methods (e.g., SIX Sigma and LEAN methods).
• Equipment Management including validation (IQ, OQ, PQ) and managing preventative maintenance and calibration requirements.
• Develop training and Quality Documentation (e.g., work instructions) for production processes.
• Provide technical support for Quality documentation within the QMS such as DCO’s, design qualifications, design transfer, activities for regulatory submissions, equipment management, product, and process development.
• Support the analysis and resolution of complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations).
• Technical engineering support for the design transfer and production of devices, as well as commercialization activities, by ensuring R&D processes are characterized and scaled up by utilizing new technology and standard work.
• Lead manufacturing support tasks; give guidance to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work where appropriate.
• Train, coach, and mentor lower-level employees on more complex procedures.
• Lead and establish complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project plan, risk analysis, etc.).
• Drive the development and execution of complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and issue reports.
Required Education and Experience:
• A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
• Must have ISO13485 Experience
• Minimum of 5 years’ experience in a medical device manufacturing environment (or other similar regulated industry) is required.
• Knowledge of equipment qualification and design verification, process validation in the medical device industry or other regulated industries is required.
• Understanding of statistical techniques is required and must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
Skills and Abilities Required for This Job:
• Must be able to work effectively and collaborate within cross-functional teams.
• Must take initiative, communicate status and objectives and be able to conduct hands-on work.
• Effective communication and project management skills are required.
• Must be able to handle multiple tasks with high attention to detail.
• Must have strong documentation skills.
• Knowledge of and experience in compliance with GMP and regulatory procedural standards in a medical device (ISO13485) environment.
• Strong interpersonal and intercultural skills are required.
• Strong investigation and problem-solving skills.
• Ability to work across various time zones and to travel if required