Provide technical manufacturing support to Operations and Engineering.
Key Responsibilities:
• Set-up and execute feasibility studies, experiments, and tests - both creating and following established protocols - to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review. Operate a variety of test equipment to assess characteristics of the manufacturing environment
• Consult with Engineers, Technicians, and Assemblers on processes to execute experiments and/or production runs. Support related to equipment investigations, testing, objective evidence of product dispositions and rework support work necessary.
• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval
• Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems
• Follow through with development of training and documentation materials, based on collaboration with Engineering, including identifying opportunities for modification and making recommendations, enabling the seamless knowledge transfer of project and manufacturing processes; applying knowledge of processes to devise process changes in collaboration with Engineering
• May lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework
• Identify potential improvement opportunities and propose solutions to optimize process and/or equipment, e.g., re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, for Engineering review
• Provide coaching and guidance to technicians
• Other incidental duties (e.g. report writing and/or data collection)
Education and Experience:
• Diploma or equivalent with 3 years of previous related experience, such as GMP, clean room, medical device, and experience with automated equipment required
Additional Skills:
• Excellent computer skills required, including experience with MS Office Suite; ERP/MRP systems experience preferred
• Ability to read, comprehend, write and speak English, and good communication skills required
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Strict attention to detail
• Ability to provide feedback in a professional, direct, and tactful manner
• Must be able to work in a team environment and with minimum supervision
• Proven success adhering to project schedules and managing small projects
• Substantial knowledge of validation and improvement of automated equipment
• Ability to troubleshoot manufacturing equipment
• Knowledge of material compatibility in the proposed use environment
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
