Position Summary
The Secondary Operations Technician is responsible for the setup, changeover, troubleshooting, preventative maintenance, and operation of specialized secondary manufacturing equipment used in the production of precision medical device components. This role ensures equipment is maintained in a validated state, operates reliably, and consistently produces products that meet customer specifications and Wytech's Quality Management System requirements.
Working within an ISO 13485-regulated medical device manufacturing environment, the technician supports production through equipment readiness, technical troubleshooting, preventative maintenance, operator support, and continuous process improvement. The technician also performs production operations as needed while maintaining compliance with Good Manufacturing Practices (GMP), documented procedures, and quality standards.
2. Schedule
· Flexible 40-hour work week.
· Overtime as required to support production.
3. Reporting Structure
· Reports to Manufacturing Engineering or Production leadership.
4. Education
· High school diploma or GED required.
· Technical training preferred.
5. Training
· On-the-job training provided.
· Training on GMP, ISO 13485, safety, equipment, and quality systems.
6. Skills & Competencies
· Mechanical aptitude.
· Hydraulic, pneumatic and mechanical troubleshooting.
· Good Documentation Practices.
· Ability to read engineering work instructions and drawings.
· Experience using precision measuring equipment.
· Strong organizational, documentation, and communication skills.
· Ability to use surface grinder to maintain tooling.
7. Experience
· 3+ years in manufacturing equipment setup, maintenance or regulated manufacturing preferred.
· Basic PLC Troubleshooting
8. Responsibilities & Authorities
· Perform machine setups and product changeovers.
· Support hydraulic press, coating removal equipment, and pneumatic trimmers.
· Perform preventative maintenance and troubleshooting.
· Complete maintenance documentation in the CMMS.
· Support operators and perform production as needed.
· Maintain equipment in a validated state.
· Comply with ISO 13485, GMP, GDP, and Wytech procedures.
· Support CAPA, NCR, and continuous improvement activities.
· Maintain tooling traceability and accurate documentation.
· Participate in Lean and Continuous Improvement initiatives.
· Support equipment qualifications and process validations (IQ/OQ/PQ).
· Operate secondary processing equipment as needed.
· Perform in-process inspections using calibrated measuring equipment.
· Inspect equipment for wear and abnormal conditions.
· Replace worn components proactively.
· Assist with development of work instructions and PM procedures.
· Respond to equipment issues to minimize downtime.
· Diagnose mechanical, pneumatic, hydraulic, and basic electrical issues.
· Support operators with machine adjustments.
· Escalate complex issues appropriately.
· Perform first-piece verification with Production and Quality personnel.
· Install and align tooling, dies, fixtures, abrasive wheels, and machine components according to work instructions.
· Maintain safe and organized work areas using 5S.
· Equipment Supported:
· Hydraulic and pneumatic presses for precision wire flattening.
· Mechanical coating removal equipment utilizing abrasive wheels and linear feed systems.
· Pneumatic trimming equipment.
· Additional secondary operation equipment as assigned.
9. Physical Requirements
· Lift up to 50 pounds.
· Stand for extended periods.
· Safely use hand tools and measuring equipment.
10. Travel
· Minimal travel; training or vendor visits as required.
11. Performance Expectations / Success Measures
· Complete PMs on time.
· Maintain high equipment uptime.
· Reduce changeover time and downtime.
· Maintain accurate documentation.
· Support quality and continuous improvement.
Pay: $22.00 - $28.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Tuition reimbursement
- Vision insurance
Work Location: In person
