Job Summary:
The Senior Maintenance Technician is responsible for maintaining, troubleshooting, repairing, improving, and installing manufacturing equipment used in the production of medical devices. This role performs preventative, predictive, and corrective maintenance activities to maximize equipment uptime, improve Overall Equipment Effectiveness (OEE), and support uninterrupted production operations.
The ideal candidate possesses strong mechanical and electrical troubleshooting skills, thrives in a regulated manufacturing environment, and demonstrates a sense of urgency when responding to equipment issues. This individual is expected to identify and eliminate root causes of equipment failures. The Senior Maintenance Technician will work closely with Production, Manufacturing Engineering, Quality, and Facilities teams to ensure equipment reliability, compliance, and operational efficiency.
Duties and Responsibilities:
Equipment Maintenance & Repair
- Perform preventative, predictive, and corrective maintenance on manufacturing equipment and support systems.
o Troubleshoot and repair production equipment such as Packaging equipment, Ultrasonic cleaning systems, IPA cleaning systems, Drying equipment, Adhesive dispensing equipment, Semi-automated assembly equipment, Screw-driving and fastening systems, Production tooling and fixtures
- Respond rapidly to equipment downtime events and restore equipment to operational status.
- Diagnose recurring equipment failures and implement permanent corrective actions.
- Analyze equipment downtime trends and recurring failures to identify opportunities for improved reliability, preventative maintenance effectiveness, and increased OEE.
- Support continuous improvement efforts to improve equipment reliability and reduce downtime.
Electrical & Controls Support
- Troubleshoot automated equipment utilizing PLC-controlled systems.
- Replace electrical components including sensors, motors, relays, power supplies, circuit boards, switches, and wiring.
- Perform basic electrical troubleshooting using meters and diagnostic tools.
- Conduct light soldering, wiring repairs, and component replacement as required.
- Coordinate with equipment manufacturers or outside service providers when advanced controls support is needed.
Mechanical Systems Support
- Diagnose and repair mechanical failures involving moving assemblies, bearings, drive systems, pneumatic components, and machine mechanisms.
- Troubleshoot and maintain pneumatic systems including regulators, valves, cylinders, and compressed air distribution systems.
- Maintain utility connections supporting manufacturing equipment including compressed air, vacuum, and process water systems.
Equipment Installation & Qualification
- Assist with installation, setup, relocation, startup, and modification of manufacturing equipment.
- Support equipment qualification activities including IQ/OQ/PQ protocols and associated documentation.
- Participate in equipment validation and process improvement projects.
- Assist in developing preventative maintenance plans for newly introduced equipment.
- Coordinate and support external contractors, equipment manufacturers, and service providers during repairs, installations, and equipment upgrades.
Documentation & Compliance
- Accurately follow established procedures, document maintenance activities, repairs, inspections, preventative maintenance records, and corrective actions.
- Complete maintenance work orders and technical summaries detailing work performed, deficiencies identified, and corrective actions implemented.
- Develop and update preventative maintenance procedures, inspection checklists, and maintenance work instructions as needed.
- Maintain compliance with FDA Quality System Regulations, ISO 13485 requirements, Good Manufacturing Practices (GMP), and internal procedures.
Cross-Functional Support
- Partner with Production, Manufacturing Engineering, Quality, and Facilities personnel to coordinate maintenance activities and minimize disruption to operations.
- Provide technical support and recommendations for equipment improvements, reliability initiatives, and capital equipment projects.
- Support implementation of safety improvements and machine modifications as required.
Qualifications:
- Minimum 10 years of maintenance experience in a manufacturing environment.
- Minimum 5 years of experience in a regulated industry such as medical devices, pharmaceuticals, biotechnology, aerospace, or similar.
- Demonstrated experience troubleshooting automated manufacturing equipment.
- Strong mechanical and electrical troubleshooting skills.
- Ability to read and interpret engineering drawings, wiring diagrams, equipment manuals, technical specifications, and manufacturer documentation.
- Strong root cause analysis and structured problem-solving skills.
- Proven ability to prioritize equipment uptime and respond effectively to production needs.
- Demonstrated ability to work independently with minimal supervision while effectively supporting cross-functional teams.
- Strong written and verbal communication skills.
- Working knowledge of Microsoft Office applications and computerized maintenance management systems (CMMS) preferred.
- Maintenance Certifications are plus.
Work Environment: While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee is frequently exposed to a variety of varying weather conditions, trash, waste, chemicals and other materials. The noise level in the work environment and facility grounds can be loud.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling and climbing all day. The employee must frequently lift or move items over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Requires travel between buildings as well as to and from retail/wholesale suppliers. May require travel to remote locations.
Pay: $85,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Retirement plan
- Vision insurance
Work Location: In person
