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Sr. Engineer
We are seeking an experienced Engineer to support the design, development, and integration of automated assembly and packaging equipment in a regulated manufacturing environment.
Key Responsibilities
Assist in developing User Requirement Specifications (URS) and mechanical/electrical designs for equipment.
Support equipment integration, including FAT, SAT, installation, and startup.
Collaborate with vendors and suppliers on capital projects, managing scope, cost, and timelines.
Support vendor contracts in partnership with procurement and legal teams.
Develop or obtain CAD models and technical drawings (2D/3D).
Maintain design documentation (URS, assembly instructions, bills of process, etc.).
Participate in design reviews, risk assessments, and FMEA activities.
Ensure compliance with safety, quality, GMP, and regulatory standards.?
Requisitos: Requirements: BS in Engineering (Mechanical, Electrical, Chemical, or related).d. Minimum 8 years of engineering experience. Background in automated manufacturing equipment and high-volume production. Experience in medical devices, pharmaceuticals, or in-vitro diagnostics (preferred). Proven experience in: Process improvements, Equipment implementation and validation, Full project lifecycle (scoping, budgeting, vendor management, installation, validation), Knowledge of labeling, barcode systems, and packaging cost analysis. Special Skills: Proficient in CAD, WORD, Excel, MS Project. Working knowledge of Minitab is a plus. Requiere Mucha Experiencia Requires Expert
Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC
Empleos en Puerto RicoJobs in Puerto Rico Ingenieros
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