Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com.
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description:
This is a hands-on Equipment & Maintenance Technician role supporting R&D and production equipment in a regulated medical device environment. The position owns preventive maintenance and calibration programs, troubleshoots mechanical/pneumatic/electrical equipment, supports IQ/OQ/PQ and CAPAs, and manages vendors, tooling, fixtures, and facility systems.
Responsibilities, Skills & Hands-On Experience:
- Own and execute the preventive maintenance program for PD and production equipment, including schedule development, PM execution, and documentation of results.
- Coordinate the equipment calibration program: schedule internal and external calibrations, track due dates, manage out-of-tolerance events, and maintain calibration records.
- Maintain equipment documentation including equipment logbooks, manuals, PM procedures, calibration certificates, and the equipment master list.
- Troubleshoot, repair, and return equipment to service; escalate to engineering or external vendors as required.
- Provide input and support for execution of Equipment Qualification and Process Validation Protocols (IQ, OQ, PQ) for new, relocated, and repaired equipment.
- Manage equipment vendor relationships including service contracts, scheduled service visits, quotes, spare parts inventory, and coordination of on-site contractor work.
- Fabricate, modify, and repair tooling and fixtures in support of PD and Production builds.
- Support facilities and utilities systems (compressed air, DI water, vacuum, and related systems) and coordinate external contractor activity.
- Support investigations and CAPAs where equipment performance is a contributing factor.
- Maintain safety, quality, and GMP/GDP standards across all manufacturing and lab areas.
- Works in accordance with quality system procedures.
- Other duties as assigned by supervisor.
Education & Work Experience:
- High School diploma required - AA/AS degree in a technical field, trade program completion, or equivalent.
- 5+ years of equipment or maintenance technician experience; medical device or other regulated manufacturing environment preferred.
- Working knowledge of mechanical, pneumatic, and basic electrical systems; ability to read schematics and assembly drawings.
- Familiarity with calibration principles, measurement traceability, and out-of-tolerance handling.
- Experience working within a quality management system with clear, contemporaneous documentation practices.
- Experience with maintenance tracking systems is a plus.
- Experience supporting IQ/OQ/PQ protocol execution is a plus.
- Machining, light fabrication, or 3-D printing experience.
- SolidWorks/ CAD is a plus.
- Excellent problem-solving skills; ability to diagnose issues, find and test solutions.
- Excellent attention to detail, flexibility, and adaptability to change.
- Effective verbal and written communication skills.
- Self-directed and organized - able to hold a recurring schedule without close supervision.
- Comfortable working in a clean room environment.
Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time, non-exempt, position is between $83,200 to $93,600 + equity + benefits.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.