What are the responsibilities and job description for the Maintenance Tech position at Shummi US LLC?
Job Overview:
We are seeking a skilled and reliable Maintenance Technician to support the maintenance, repair, and calibration of medical device manufacturing equipment and systems. The ideal candidate will ensure compliance with industry standards, perform preventive maintenance, troubleshoot technical issues, and help maintain a safe and efficient production environment.
Key Responsibilities:
- Perform routine maintenance and inspections on medical device manufacturing equipment and machinery to ensure optimal performance.
- Troubleshoot and repair electrical, mechanical, and automated systems used in medical device production.
- Ensure all equipment meets regulatory compliance standards (e.g., FDA, ISO) and internal quality controls.
- Calibrate and validate equipment as required, ensuring accuracy and adherence to company specifications.
- Maintain accurate records of maintenance activities, repairs, and calibration results, following good documentation practices (GDP).
- Respond promptly to emergency maintenance requests to minimize downtime.
- Collaborate with the quality and production teams to address equipment issues and improve manufacturing processes.
- Assist in the installation and setup of new equipment or technology in compliance with safety and regulatory guidelines.
- Conduct periodic safety checks and ensure maintenance procedures align with health and safety standards.
- Perform general facility maintenance duties, including HVAC, plumbing, and electrical work, as needed.
Qualifications:
- High school diploma or equivalent; Associate’s degree or technical certification in a related field (e.g., Biomedical Engineering, Electrical Engineering) preferred.
- Proven experience as a Maintenance Technician, preferably in a regulated manufacturing or medical device environment.
- Strong knowledge of mechanical, electrical, and automated systems used in medical device production.
- Familiarity with medical device regulatory standards (FDA, ISO 13485).
- Strong troubleshooting and problem-solving skills, with attention to detail.
- Good documentation practices (GDP) and understanding of regulatory compliance.
- Excellent communication and teamwork skills, with the ability to collaborate across departments.
- Ability to work independently, efficiently manage time, and prioritize tasks.
- Physical stamina to perform maintenance tasks and lift heavy objects (as needed).
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Work Location: In person