Lead Mechanical Test Lab Manager - Medical Devices

SI-BONE, Inc; San Jose (CA); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

SI-BONE, Inc is seeking a Test Lab Manager in California to oversee a mechanical testing laboratory. You will plan, execute, and document mechanical tests, maintain equipment, and support regulatory compliance while coordinating with project teams.

The role emphasizes data integrity, adherence to ASTM/ISO standards, and collaboration across engineering and QA to ensure traceable, high-quality results in a fast-paced medical-device environment.

Formación

• BS in an engineering discipline (Mechanical engineering preferred).
• 5+ years hands-on experience with mechanical testing equipment (e.g., Instron, MTS). Proficiency designing test fixtures and handling fabrication.
• Familiarity with ASTM and ISO standards including static and dynamic testing. Preference for orthopedics and/or spine.
• Data Integrity with traceable documentation to ensure compliance and repeatable results.
• Strong communication and writing skills; proficiency with Microsoft Office tools.

Responsabilidades

• Direct daily mechanical testing lab functions including test execution and reporting.
• Collaborate with test requestors and project management on test scheduling across projects.
• Manage equipment calibration, maintenance, and resources.
• Hold non-compliant documentation from shipment or processing and report issues to supervisor.
• Support the SI-BONE Quality System and regulatory requirements.

Conocimientos

Equipment Proficiency

Knowledge of Standards

Data Integrity

Communication

Safety

Educación

BS in engineering (Mechanical preferred)

Herramientas

Instron

MTS

Fixture design

Descripción del empleo

SI-BONE, Inc is seeking a Test Lab Manager in California to oversee a mechanical testing laboratory. You will plan, execute, and document mechanical tests, maintain equipment, and support regulatory compliance while coordinating with project teams.

The role emphasizes data integrity, adherence to ASTM/ISO standards, and collaboration across engineering and QA to ensure traceable, high-quality results in a fast-paced medical-device environment.