Responsibilities:
Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment.
Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits.
Establish preventive maintenance plans, calibration schedules, and critical spare parts lists.
Author validation plans, validation protocols, test reports, including deviations and corrective actions and Standard Operating Procedures (SOPs).
Utilize tools such as Minitab to analyze large datasets from sensor builds, performing Design of Experiments (DOE) and process capability studies.
Perform equipment risk assessments, including pFMEA and hazard analysis.
Define User Requirements Specifications (URS) for new equipment and lead equipment installation and commissioning efforts.
Train technicians and operators on validated equipment procedures.
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
Partner with R&D, Quality Assurance, and external vendors to scale up pilot lines to high‐volume production.
Work with Manufacturing Engineers to improve equipment reliability and throughput.
Support internal and external audits by providing equipment validation evidence.
Requirements:
Bachelor's degree in mechanical, Electrical, Industrial, Biomedical Engineering, or a related field.
3+ years of equipment validation experience within medical device manufacturing.
Strong understanding of GMP, GAMP 5, and FDA equipment validation requirements.
Familiarity with automated equipment, robotics, PLCs, and machine vision systems.
Preferred Qualifications:
Prior experience validating equipment for biosensor or electrochemical sensor manufacturing, or experience in the semiconductor industry for wafer production.
Experience with high‐speed automation and semi‐automated production lines.
Certification in equipment validation or GAMP 5 training.
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