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 :
H.S. Diploma or equivalent 7 years years experience of previous related experience, such as GMP, clean room, medical device, and experience with automated equipment Required
Associate's Degree or equivalent Preferred
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 EHS rules and requirements 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