Senior Medical Equipment Technician – GMP & Calibration

Supira Medical, Inc.; Los Gatos (CA); Sur place; USD 83 000 - 94 000; Plein temps

Avantages offerts par ce poste

Equity

Benefits

Résumé du poste

Supira Medical, Inc. is seeking an Equipment & Maintenance Technician to support R&D and production equipment in a regulated medical device environment.

The role owns preventive maintenance, calibration, and documentation, and collaborates with engineering and vendors to ensure equipment stays in specification. The ideal candidate has 5+ years of maintenance experience, reads schematics, understands calibration traceability, and can operate within GMP/GDP standards.

Qualifications

• 5+ years of equipment or maintenance technician experience in a regulated environment.
• Ability to read schematics and assembly drawings.
• Familiarity with calibration principles and measurement traceability.
• Experience with quality management systems and contemporaneous documentation.
• Experience supporting IQ/OQ/PQ protocols is a plus.
• Machining, light fabrication, or 3-D printing experience is a plus.
• Solid problem-solving and detail-oriented mindset.

Responsabilités

• Own and execute the preventive maintenance program for PD and production equipment, including PM scheduling and documentation.
• Coordinate equipment calibration program: schedule, track due dates, manage out-of-tolerance events, maintain records.
• Maintain equipment documentation: logbooks, manuals, PM procedures, calibration certificates, master list.
• Troubleshoot, repair, and return equipment to service; escalate to engineering or vendors as needed.
• Provide input and support for IQ/OQ/PQ and process validation protocols for equipment.
• Manage equipment vendor relationships: service contracts, visits, quotes, spare parts inventory, on-site contractor coordination.
• Fabricate, modify, and repair tooling and fixtures for PD/production builds.
• Support facilities and utilities systems and coordinate external contractor activity.
• Support investigations and CAPAs related to equipment performance.
• Maintain GMP/GDP standards across manufacturing and lab areas.

Connaissances

Problem solving

Attention to detail

Communication skills

Self-directed/organized

Clean room experience

Formation

AA/AS degree in a technical field

High School diploma or equivalent

Outils

SolidWorks

CAD

Description du poste

Supira Medical, Inc. is seeking an Equipment & Maintenance Technician to support R&D and production equipment in a regulated medical device environment.

The role owns preventive maintenance, calibration, and documentation, and collaborates with engineering and vendors to ensure equipment stays in specification. The ideal candidate has 5+ years of maintenance experience, reads schematics, understands calibration traceability, and can operate within GMP/GDP standards.