Automation Engineering Tech II
ELS Technology S.a.r.l, PR
Localização do trabalho
Añasco
Status de emprego
Tempo total
Detalhes sobre a oferta de trabalho
Provides technical manufacturing support to Operations and Engineering.
Key Responsibilities:
• Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework; manage all aspects of project management, using such tools as Microsoft Project, Gantt charts, etc., to ensure on-time and on-budget project completion, including interfacing with all parties, allocating resources, negotiating competing priorities, mediating conflicting objectives, and escalating issues as needed for resolution.
• Develop training and documentation materials, based on collaboration with Engineering and cross-functional counterparts; may also develop work independently and present findings of opportunities for modification and making recommendations to advance the seamless knowledge transfer of project and manufacturing processes; applying in-depth knowledge of processes in the use of machines to ensure successful outcomes, as well as to devise complex process changes in collaboration with Engineering.
• Design, 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.
• Develop proposals and make recommendations to Engineers, Technicians, and Assemblers on complex processes, modification and improvements; and may lead the execution of experiments and/or production runs.
• 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.
• Collaborate with Engineering in translating designs into practical machining specifications.
• Provide coaching and guidance to technicians.
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.
• Other incidental duties (e.g. report writing and/or data collection).
Education and Experience:
• H.S. Diploma or equivalent 9 years experience previous related experience, such as GMP, clean room, medical device, and experience with automated equipment, required.
• Associate's Degree or equivalent, preferred.
• Availability to work rotating shifts, holidays, and weekends.
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 and interpersonal skills required, including the ability to convey instructions and training, and effectively persuade and negotiate to drive achievement of objectives.
• 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.
• Moderate knowledge of validation and improvement of automated equipment.
• Full knowledge of validation and improvement of automated equipment.
• Ability to troubleshoot manufacturing equipment.
• Knowledge of material compatibility in the proposed use environment.
• Accountable to adhere to applicable Edwards Environmental, Health and Safety and Quality System requirements to ensure our products and services consistently meet customer and regulatory.
• 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.
• Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel
