Medical Device Assembly Technician

IntePros is currently looking for an Medical Device Assembly Technician to join one of our medical device/manufacturing clients in Tempe, AZ. The Medical Device Assembly Technician will provide engineering support on duties such as inspection, processing and managing non-conforming materials (NCMRs), supporting production with quality issues and production process audits/inspections as well as supporting incoming inspection and reporting and working with suppliers on CAPAs. Key Responsibilities • Perform and recommend appropriate quality controls, process testing, and corrective actions to maintain product and process integrity. • Troubleshoot and resolve quality issues related to production orders and manufacturing processes. • Monitor and analyze product quality data to identify trends, support root cause analysis, and recommend corrective or follow-up actions. • Conduct and report findings from Cp/Cpk studies, window studies, Design of Experiments (DOE), First Article Inspections (FAI), and other statistical or analytical methods used for mold and process qualification. • Support engineering teams in developing, implementing, and refining quality plans, procedures, and systems. • Provide project and program updates to internal and external stakeholders. • Assist with project planning, including schedules, budgets, status reports, and progress tracking. • Support Lean Six Sigma and continuous improvement initiatives to improve quality, efficiency, and manufacturing performance. • Follow all applicable SOPs, GMP requirements, ISO standards, safety policies, quality procedures, and company regulations. • Maintain accurate documentation and communicate project status, workload, issues, and progress to management. • Provide a high level of customer service when working with internal and external stakeholders. • Maintain a clean, organized, and safe work environment. Education & Experience • Bachelor’s degree in Engineering or a related field from an accredited four-year institution, or equivalent relevant work experience. • Previous manufacturing, engineering, or quality experience is beneficial. • Lean Six Sigma certification preferred. • Experience working within ISO- and GMP-regulated manufacturing environments preferred. Knowledge, Skills & Abilities • Working knowledge of quality tools, systems, and manufacturing processes. • Ability to understand and interpret mechanical drawings and technical documentation. • Familiarity with Cp/Cpk, DOE, First Article Inspection, statistical analysis, and process qualification. • Strong troubleshooting, analytical, and problem-solving skills. • Highly proficient with Microsoft Office applications. • Strong organizational skills with excellent attention to detail and accuracy. • Ability to work effectively with engineering, manufacturing, quality, and other cross-functional teams. • Knowledge of applicable SOPs, ISO standards, GMP requirements, and quality systems. • Ability to support Lean/Six Sigma initiatives and continuous improvement activities. Physical Requirements • Ability to exert up to 20 lbs./9 kg of force as required to perform job responsibilities.