Senior Medical Device Service & Recertification Engineer

Galvanize; Redwood City (CA); In loco; USD 120.000 - 150.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k)

Paid Time Off

Descrizione del lavoro

Galvanize Therapeutics is seeking an onsite engineer in Redwood City, CA to troubleshoot, repair, and calibrate medical devices, and to develop refurbishing and recertification processes ensuring safety and regulatory compliance.

You will read schematics, use diagnostic tools, and mentor technicians, contributing to continuous improvement in manufacturing, testing, and service operations. Competitive salary plus comprehensive benefits are offered.

Competenze

• Bachelor's degree in Electrical, Biomedical, Mechanical, Manufacturing or related discipline.
• 5+ years in medical device engineering, service, repair, recertification, manufacturing, or related regulated field.
• Strong hands-on troubleshooting across electrical, electronics, mechanical, and electromechanical domains.
• Experience with medical devices, electronics, or other regulated products.
• Ability to read electrical schematics, wiring diagrams, and service manuals.
• Experience with diagnostic tools, service software, and firmware updates.
• Knowledge of ESD controls in production environments.
• Strong problem-solving, root-cause analysis, and FMEA capabilities.
• Experience mentoring or supervising technicians.
• Ability to document technical work clearly.
• Experience with IQ/OQ/PQ and validation/verification.
• Familiarity with lean manufacturing and continuous improvement.
• Ability to work independently in onsite environment.
• Familiarity with ISO 13485, FDA requirements, CAPA and medical device QMS.
• Prior servicing experience with medical devices preferred.

Mansioni

• Troubleshoot, diagnose, repair, test, calibrate, and maintain medical devices.
• Perform complex troubleshooting using schematics, service docs, system data, and diagnostic tools.
• Respond to service needs to support system reliability and uptime.
• Analyze discrepant components and field returns; identify root causes and corrective actions.
• Provide remote technical support and collaborate with R&D, Quality, and Customer Service.
• Supervise, train and mentor technicians on device operation, troubleshooting, and safety.
• Manage spare parts, tools, and service equipment per controls.
• Develop, validate, and improve processes for inspecting, repairing, and recertifying devices.
• Establish acceptance criteria to ensure device safety and quality.

Conoscenze

Troubleshooting

Electrical/EM systems

Schematics & manuals

Root cause analysis

Mentoring technicians

Documentation & reporting

Formazione

Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related discipline

Strumenti

Diagnostic equipment

Service software

Electrical test equipment

IQ/OQ/PQ knowledge

Oracle NetSuite

Arena

Descrizione del lavoro

Galvanize Therapeutics is seeking an onsite engineer in Redwood City, CA to troubleshoot, repair, and calibrate medical devices, and to develop refurbishing and recertification processes ensuring safety and regulatory compliance.

You will read schematics, use diagnostic tools, and mentor technicians, contributing to continuous improvement in manufacturing, testing, and service operations. Competitive salary plus comprehensive benefits are offered.