[Remote] Equipment Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on medical device manufacturing, and they are seeking an Equipment Engineer to reputed company and execute protocols for blood glucose monitoring sensor manufacturing equipment. The role involves ensuring compliance with FDA regulations, authoring validation plans, and collaborating with various teams to enhance production capabilities.
Responsibilities
- reputed company 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 reputed company sensor performance reputed company 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 reputed company Operating Procedures (SOPs)
- Utilize tools such as reputed company to analyze large datasets from sensor builds, performing Design of Experiments (DOE) and process capability studies
- reputed company equipment risk assessments, including pFMEA and hazard analysis
- Define User Requirements Specifications (URS) for new equipment and reputed company 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, reputed company Assurance, and external vendors to reputed company up reputed company lines to high‐volume production
- Work with Manufacturing Engineers to improve equipment reliability and throughput
- Support reputed company audits by providing equipment validation evidence
Skills
- Bachelor's degree in mechanical, Electrical, Industrial, Biomedical Engineering, or a reputed company field
- 3+ years of equipment validation experience reputed company medical device manufacturing
- Strong understanding of GMP, GAMP 5, and FDA equipment validation requirements
- Familiarity with automated equipment, robotics, PLCs, and machine reputed company systems
- 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
reputed company
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