Manufacturing Technician III is responsible for advanced electro‑mechanical assembly of robotic modules and components, supporting production schedules, and maintaining compliance with medical device regulations (reports into Surgical Robotics (OTTAVA) Manufacturing). Key Responsibilities Perform advanced electro‑mechanical assembly and system‑level integration of robotic modules (joints, control modules, sensors, cable harnesses) using work instructions and engineering documentation. Meet daily build targets in a structured production environment while complying with ISO 13485, FDA QSR, and GDP. Interpret and apply assembly procedures, MPIs, TPIs, and engineering documents to build, verify, and validate components across multiple product modules. Conduct functional, electrical, mechanical, and diagnostic testing using calibrated equipment and test procedures. Troubleshoot, diagnose, and rework complex electrical/mechanical issues; elevate to engineering. Maintain compliance with ESD protection, clean manufacturing protocols, and contamination control standards. Document production, inspection, rework, and testing results in MES, ERP/SAP, and electronic DHR systems per GDP/GMP. Perform in‑process inspections and support quality verifications. Participate in quality improvement initiatives (including investigations and CAPA support). Collaborate with Manufacturing leadership, NPI engineering, Quality, and Operations to support pilot builds and introductions. Provide feedback to engineering to improve MWI/MPI/TPI. Support training and on‑the‑job guidance for Technician I/II. Maintain certification and multi‑module proficiency across at least five major robotic system modules. Prepare production lines (line clearance; verify equipment maintenance/calibration). Maintain material transaction accuracy and perform cycle counts for inventory. Report material shortages/discrepancies to prevent build interruptions. Identify workflow bottlenecks and support process efficiency improvements. Qualifications Education Vocational certificate, technical, or associate degree (or equivalent) required. Required 4–5 years in medical device or electromechanical capital equipment manufacturing, with demonstrated GDP use in a regulated environment. Strong mechanical aptitude; ability to troubleshoot and support root cause investigations. Electrical troubleshooting proficiency (e.g., multimeters, grounding/isolation, diagnostic evaluation). Ability to complete multiple assembly/testing tasks while meeting workmanship, safety, and productivity expectations. Knowledge of ESD principles and hands‑on ESD controls. Proficiency with precision assembly tools (torque wrenches, screwdrivers, calipers, tweezers, multimeters, presses, IPA, adhesives such as Loctite). Familiarity with ISO 13485, FDA QSR, and clean manufacturing practices. Effective communication/collaboration across manufacturing, engineering, quality, and operations. Ability to work independently in a fast‑paced environment. Flexibility for overtime, early shifts, and weekends. Initiative and commitment to continuous improvement and GDP/GMP adherence. Preferred Experience with robotics/motion‑control or surgical device assembly with advanced troubleshooting. Working knowledge of process validation activities (IQ/OQ/PQ) and fixture validation. Exposure to continuous improvement methodologies. Work Schedule Monday–Friday, 6:00 AM–2:30 PM (onsite); occasional evenings/weekends and overtime based on demand. Required Skills (from posting) Accountability Assembly Operations Execution Focus Good Manufacturing Practices (GMP) Process/Manufacturing Processes Mechanical Equipments Plant Operations Organizing Repair Management Technologically Savvy #J-18808-Ljbffr
Manufacturing Tech Iii
SCORPION THERAPEUTICS
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Publicado hace 7 días
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