Equipment Engineer

Katalyst CRO; Dallas (TX); On-site; USD 95,000 - 130,000; Full time

Job summary

Katalyst CRO in Dallas, TX seeks an Equipment Validation Engineer to develop and execute IQ/OQ/PQ protocols for glucose sensor manufacturing equipment. You will define CPPs, set maintenance plans, and author validation documentation to ensure devices meet regulatory standards.

You will leverage Minitab for DOE, perform risk assessments, and mentor technicians while collaborating with R&D, QA, and external vendors to scale pilot lines to high-volume production in a regulated medical device

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Industrial, Biomedical Engineering or related field.
• 3+ years of equipment validation experience in medical device manufacturing.
• Strong understanding of GMP, GAMP 5, and FDA equipment validation requirements.
• Familiarity with automated equipment, robotics, PLCs, and machine vision systems.

Responsibilities

• Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for blood glucose monitoring sensor manufacturing equipment.
• Define and document CPPs and equipment capabilities to ensure stable sensor performance within spec limits.
• Establish preventive maintenance plans, calibration schedules, and critical spare parts lists.
• Author validation plans, validation protocols, test reports, deviations and corrective actions and SOPs.
• Utilize Minitab to analyze large datasets, perform DOE and process capability studies.
• Perform equipment risk assessments including pFMEA and hazard analysis.
• Define URS for new equipment and lead installation and commissioning.
• Train technicians and operators on validated equipment procedures.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP.
• Partner with R&D, QA and vendors to scale pilot lines to high-volume production.
• Collaborate with Manufacturing Engineers to improve reliability and throughput.
• Support audits with equipment validation evidence.

Skills

IQ/OQ/PQ protocols

DOE

Process capability studies

Validation planning

Calibration and maintenance planning

Training technicians

Regulatory compliance

Education

Bachelor's degree in Mechanical, Electrical, Industrial, Biomedical Engineering

Tools

Minitab

PLCs

Machine vision systems

Job description

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 highvolume production.
• Work with Manufacturing Engineers to improve equipment reliability and throughput.
• Support internal and external audits by providing equipment validation evidence.

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 highvolume 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 highspeed automation and semiautomated production lines.
• Certification in equipment validation or GAMP 5 training.