Process Engineer
Job DescriptionJob Description
Responsibilities:
- Process Design & Optimization: Develop and improve maintenance processes for electronic systems and equipment within the servicing facility, focusing on efficiency, quality, and cost-effectiveness.
- IQ/OQ Implementation: Lead the implementation, execution, and documentation of IQ/OQ protocols for equipment and systems used in the facility. Ensure all systems and processes comply with regulatory standards before deployment in maintenance and service operations.
- Electronic Systems Support: Oversee the troubleshooting, repair, and servicing of complex electronic systems, ensuring that all equipment is properly maintained and meets operational requirements.
- Process Improvement & Lean Manufacturing: Identify and implement continuous improvement initiatives in maintenance workflows, leveraging Lean, Six Sigma, and other best practices to optimize service processes and reduce downtime.
- Equipment Qualification & Maintenance: Manage the qualification, calibration, and routine maintenance of testing and diagnostic equipment. Ensure all equipment is serviced according to predefined schedules and maintains high performance.
- Compliance & Quality Control: Ensure that all servicing processes meet industry standards, regulatory requirements, and internal quality guidelines (ISO, FDA, GMP, etc.). Support audits and maintain detailed documentation related to IQ/OQ activities.
- Troubleshooting & Technical Support: Provide technical expertise to the maintenance team, resolving issues related to electronic systems and equipment. Address equipment failures, system errors, and perform root cause analysis for recurring issues.
- Documentation & Reporting: Develop and maintain standard operating procedures (SOPs) for servicing and maintenance tasks. Document and track IQ/OQ protocols and any corrective actions taken. Prepare reports on process performance and improvement initiatives.
- Cross-Functional Collaboration: Work closely with the maintenance, engineering, and operations teams to ensure smooth workflow integration and minimize equipment downtime. Coordinate with suppliers and vendors for technical support as needed.
- Training & Mentorship: Provide training to staff on proper maintenance procedures, handling of electronic systems, and compliance with IQ/OQ requirements. Ensure that technicians are up-to-date on industry best practices and safety standards.
- Data Analysis & Process Monitoring: Monitor key performance indicators (KPIs) related to equipment uptime, service efficiency, and process quality. Utilize data analysis tools to evaluate process performance and implement corrective actions.
Requirements:
- Education: Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
Experience:
- Minimum of 3 years of experience as a Process Engineer, with significant exposure to maintenance and servicing of electronic systems.
- Proven experience in implementing IQ/OQ protocols for equipment and systems, especially in regulated environments.
- Hands-on experience with electronic troubleshooting, repair, and system diagnostics.
Technical Skills:
- Strong understanding of electronic systems and their components, including sensors, circuit boards, power supplies, and other electrical components.
- Experience with equipment qualification, calibration, and preventive maintenance procedures.
- Proficient in the use of process design tools, maintenance management software, and data analysis techniques.
- Familiarity with industry standards such as ISO, FDA, GMP, and others
- Problem-Solving Skills: Strong ability to analyze technical issues, perform root cause analysis, and implement corrective actions.
- Communication Skills: Excellent verbal and written communication skills, with the ability to work cross-functionally and train staff effectively.
Qualifications
- Certifications: Six Sigma, Lean Manufacturing, or other process improvement certifications.
- Experience: Prior experience in the servicing and maintenance of electronic equipment in industries such as medical devices, aerospace, or high-tech manufacturing.
- Technical Expertise: Knowledge of specialized electronic diagnostic tools, service manuals, and testing equipment.
Benefits
- Competitive salary
- Opportunities for career growth and professional development.
- Collaborative and innovative work environment.
Company DescriptionWe are looking for an excellent team player with professional work ethics to join us for a new exciting role. Successful candidates will be assigned to work on the latest surgical and imaging technologies!Company DescriptionWe are looking for an excellent team player with professional work ethics to join us for a new exciting role. Successful candidates will be assigned to work on the latest surgical and imaging technologies!