|
DescripciónDescription
The Manufacturing Engineer II, Life Cycle Management (LCM) will work within Engineering group to support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing products. Will also provide technical expertise and project leadership in the areas of medical device life cycle management, supplier change management, COGs, process development, validation and production stability. Responsible for reviewing and updating applicable product specifications and drawings for legacy products. Develop and issue change control documentation to address changes in components and/or raw materials requested by the suppliers following applicable procedures. Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, as well as manufacturing process improvements.
|
Requisitos Requirements
BS Engineering, (Mechanical, Industrial, Electrical, Chemical, Biomedical) or sciences. Professional Engineer License & Lean/Six Sigma Green or Black Belt Certification is a plus. Minimum of 4-6 years of experience in medical device and/or pharmaceutical manufacturing environment. Experience in validations: manufacturing equipment and processes, stability or aging. Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements. Strong Project Management skills. Ability to lead teams through complex projects with technical leadership. Excellent communication skills in Spanish and English (read, write and speak). Able to develop technical documentation such as: Change Controls, Validation Plans & Protocols, Technical/investigation reports, SOP, etc. Teamwork oriented and self-starter. Temporary position (one year) 1495
|
