Responsibilities:

\nSet up, calibrate, and operate basic manufacturing equipment in accordance with production schedules and quality standards.\nAssemble electromechanical subassemblies and finished medical devices, including handling small precision components.\nPerform functional and electrical testing using automated equipment and manual instruments (oscilloscope, multimeter, function generator).\nTroubleshoot technical issues related to product lines and manufacturing processes to minimize defects; escalate complex issues as needed.\nConduct electrical testing of medical device hardware in compliance with regulatory and quality standards.\nSupport rework, repair, servicing, and refurbishment of nonconforming products.\nPerform routine and preventive maintenance on production equipment; document activities in CMMS (InforEAM).\nMaintain accurate production and quality documentation, including Device History Records (DHR), ensuring traceability and compliance.\nUtilize electronic systems and software tools for data collection and production tracking.\nAdhere strictly to FDA regulations, Quality Management System (QMS), and Environmental Health & Safety procedures.\nSupport engineering initiatives such as process validation, continuous improvement, and new product introduction (NPI).\nIdentify opportunities to improve manufacturing efficiency, yields, and productivity.\nManage priorities across multiple product lines with minimal supervision.\nProvide cross-functional support and training to team members as needed.\nCommunicate effectively with manufacturing, engineering, and quality teams.\nInterpret technical documents including SOPs, work instructions, and engineering drawings.\nSupport audits, inspections, and collaborate with internal teams, vendors, and contractors\n

Requirements:

\nTypically 0-2 years of relevant manufacturing or production experience (medical device or regulated industry preferred).\n

Key Skills:

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Preferred Experience:

\nMedical device or highly regulated manufacturing environment\nExperience with cleanroom operations\nFamiliarity with CMMS systems (InforEAM)\nExposure to QMS, EMS, and compliance standards\nContinuous improvement or lean manufacturing experience\n

Education:

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