- Responsible for assigned line output, safety, yield and quality. Responsible for identification of product defects and determination of operational and process related actions to reduce the defects. This may also include equipment troubleshooting and sub-sequent work order request.
- Work with line support team (QC Supervisor, Mfg Supervisor, Quality Engineer and Operations) to perform line situation triage and determine if non-conformance is present, determine initial bracketing and containment, and support generation of ER, if needed.
- Responsible for product/process knowledge and understanding of basic cause and effect of line and process changes.
• Responsible for providing the line with related Engineering fixes, such as tooling (TLTs) and Manufacturing Aids( from idea definition to implementation) - Support maintenance technicians and supervisors in equipment availability issues. Review equipment work order completion and performs product impact analysis in order to release equipment for commercial manufacturing use.
- Support Training and Certification Program.
- Responsible for determining quality impact of Out-of-Tolerance documents.
- Responsible for execution of line related change management (material, equipment and process changes). Responsible for CO and simple CR generation related to changes impacting the manufacturing line.
- Responsible for simple continuous improvement projects development and execution.
- Responsible for exception subtask execution.
- Evaluate ideas from the LPI program for potential implementation.
- Leads root cause analysis efforts for basic/simple manufacturing events, utilizing DMAIC model and A3s. Supports CAPA (Major) investigations with data gathering and analysis as needed.
- Run studies and validations on the line as needed. Writes protocols and reports with oversight.
• Line support representative for related projects such as yield improvements, CIP's, productivity, quality and safety. - Responsible for coordination of product builds through the NPI process.
- Generate simple changes to the eLHR system.
- Demonstrate basic understanding of regulations (Compliance and EHS) for work area. Provides recommendations for improvement and executes as needed. May initiate, investigate and/or approve CAPA records.
- Support EHS and/or Reg Compliance audits.
- Bachelor degree in Engineering. Mechanical, Industrial and Chemical Engineering are preferred.
- Minimum 2 years of relevant experiences in line support for manufacturing engineering is preferred. Experience in medical device industry is preferred.
- Knowledge of applicable US & non US applicable regulations.
- Knowledge and proficiency in the application and principles of engineering.
- Ability to effectively communicate cross-functionally to assist with resolving Quality/Engineering issues.
- Bilingual (English and Spanish). Excellent written, verbal and interpersonal communication skills in both English and Spanish Knowledge of common office applications: Word, PowerPoint, Excel.
- Ability to evaluate complex processes.
- Ability to interact effectively with all levels of employees.
- Basic Statistics Knowledge is desirable.
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Manufacturing Process Engineer - Arecibo, Puerto Rico - Abbott
hace 1 semana
Descripción
The Opportunity
As a Manufacturing Process Engineer you will serve as the primary engineering personnel supporting manufacturing operations in Abbott Vascular manufacturing site, located in Barceloneta, Puerto Rico. The individual performing this role will have to create a strong teamwork with the line supervisor, Quality Engineer and operators to address all the opportunities found in the assigned manufacturing line. He/She will be accountable on quality, safety, output and yield of the assigned manufacturing line. He/She will serve as the engineering management representative in the manufacturing line, executing initiatives and working directly with the DL workforce. This person may also have a role beyond the line support engineering as a sustaining engineer for the department.
What You'll Work On
Qualifications
