Medical Device Assembly Technician

Intepros; Tempe (AZ); On-site; USD 65,000 - 90,000; Full time

Job summary

IntePros is seeking an Medical Device Assembly Technician in Tempe, AZ to provide engineering support in inspection, non-conforming materials, and quality issue resolution. The role includes assisting with production process audits, supplier CAPAs, and documentation while upholding GMP/ISO standards.

The ideal candidate has a engineering background, experience with ISO/GMP environments, and strong problem-solving skills.

Qualifications

• 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.
• Experience working within ISO- and GMP-regulated manufacturing environments preferred.

Responsibilities

• Perform and recommend quality controls, process testing, and corrective actions to maintain product/process integrity.
• Troubleshoot and resolve quality issues related to production orders and manufacturing processes.
• Monitor and analyze product quality data to identify trends and support root cause analysis.
• Conduct Cp/Cpk, DOE, FAI, and other studies for mold and process qualification.
• Support engineering teams in developing and refining quality plans, procedures, and systems.
• Provide project updates to internal and external stakeholders.
• Assist with project planning, including schedules, budgets, and progress tracking.
• Support Lean Six Sigma and continuous improvement initiatives to improve quality and manufacturing performance.
• Follow SOPs, GMP requirements, ISO standards, safety policies, and company regulations.
• Maintain accurate documentation and communicate project status to management.
• Provide high level customer service when working with stakeholders.
• Maintain a clean, organized, and safe work environment.

Skills

Quality tools

Cp/Cpk

DOE

First Article Inspections

Analytical problem-solving

Microsoft Office

Cross-functional teamwork

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

Job description

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.
• 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.