Sr. Mechanical Engineer - Hybrid Jobot
Dallas, TX10 days ago
- $145,000–$165,000 Per Year
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Skills
- Analysis Skillsunmatched
- Automationunmatched
- Biomedical Engineeringunmatched
- Calendar Managementunmatched
- Calibrationunmatched
- Code of Federal Regulationsunmatched
- Commissioningunmatched
- Corrective Actionunmatched
- Data Setsunmatched
- Electricityunmatched
- Electrochemistryunmatched
- Equipment Validationunmatched
- Experiment Designunmatched
- External Auditunmatched
- FDA (Food and Drug Administration)unmatched
- FDA Requirementsunmatched
- GMP (Good Manufacturing Practices)unmatched
- Hazard Analysisunmatched
- ISO (International Organization for Standardization)unmatched
- Industrial Engineeringunmatched
- Internal Auditunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Engineeringunmatched
- Manufacturing Equipmentunmatched
- Medical Equipmentunmatched
- Minitabunmatched
- Preventative Maintenanceunmatched
- Process Capabilityunmatched
- Process Failure Mode and Effects Analysis (PFMEA)unmatched
- Process Validationunmatched
- Production Volumeunmatched
- Programmable Logic Controller (PLC)unmatched
- Quality Assuranceunmatched
- Regulationsunmatched
- Reliability Engineeringunmatched
- Requirements Managementunmatched
- Research & Development (R&D)unmatched
- Risk Analysisunmatched
- Roboticsunmatched
- Semiconductorsunmatched
- Standard Operating Procedures (SOP)unmatched
- United States Department of Energy (DOE)unmatched
- Validation Planunmatched
- Validation Testingunmatched
- Wafer Manufacturingunmatched
- Writing Skillsunmatched
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.
- 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.
- 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.
Numbers & Facts
| Location | Dallas, TX |
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