3+ years of medical device manufacturing equipment validation experience
Strong knowledge of GMP, GAMP 5, and FDA validation
Familiarity with automated equipment, robotics, PLCs, and machine vision systems
Responsibilities
Develop and execute IQ/OQ/PQ protocols for blood glucose monitoring sensors
Document critical process parameters and equipment capabilities
Establish preventive maintenance plans and calibration schedules
Author validation plans and Standard Operating Procedures (SOPs)
Analyze large datasets using Minitab, including Design of Experiments
Conduct equipment risk assessments such as pFMEA
Define User Requirements Specifications for new equipment
Train technicians and operators on validated procedures
Ensure compliance with FDA and ISO regulations
Collaborate with R&D and vendors for production scaling
Work with Manufacturing Engineers to enhance equipment reliability
Support audits by providing validation evidence
Benefits
Professional development opportunities
Collaborative work environment
Access to cutting-edge technology
Comprehensive health and wellness programs
Flexible work hours or remote work options
Full 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 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.
