Equipment Engineer
Katalyst CRO · Dallas, TX · 2 wk ago
On-siteEngineeringContract
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.