Director, Quality Engineering - Medical Devices

SI-BONE; San Jose (CA); Presencial; USD 210.000 - 235.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus potential

Stock options

Descripción de la vacante

SI-BONE is seeking a Director of Quality Engineering to lead the technical quality function across product development, manufacturing, suppliers, and sustaining engineering. This role requires deep engineering expertise, strong statistics, and decisive judgment to translate requirements into robust controls.

You will challenge assumptions, guide solutions, and partner with cross-functional teams to ensure quality and compliance for sacroiliac joint devices and related products.

Formación

• Bachelor's degree in engineering or a closely related technical discipline.
• At least 10 years of progressively responsible, hands-on experience in medical-device quality engineering or related roles.
• Experience managing engineering personnel and developing team capabilities.
• Experience with external suppliers or contract manufacturers on technical qualification and process controls.

Responsabilidades

• Lead Quality Engineering team and set technical direction for product development, design transfer and sustaining activities.
• Provide independent quality judgment in cross-functional decisions and communicate risks and evidence gaps.
• Partner with Quality Systems to ensure alignment with quality-system processes and proper documentation.
• Lead manufacturing and sustaining activities with contract manufacturers and risk-based validation.
• Oversee supplier quality interfaces, qualification strategies, and supplier audits.
• Establish scientifically sound statistical methods for testing, process qualification, and monitoring.

Conocimientos

Design controls

Risk management

Verification and validation

Design transfer

Process validation

Supplier quality engineering

Statistical analysis

Cross-functional leadership

Educación

Bachelor's degree in engineering

ASQ CQE certification

Descripción del empleo

SI-BONE is seeking a Director of Quality Engineering to lead the technical quality function across product development, manufacturing, suppliers, and sustaining engineering. This role requires deep engineering expertise, strong statistics, and decisive judgment to translate requirements into robust controls.

You will challenge assumptions, guide solutions, and partner with cross-functional teams to ensure quality and compliance for sacroiliac joint devices and related products.