Principal Quality Engineer – Medical Devices & Compliance

Pulse Biosciences, Inc.; Hayward (CA); Presencial; USD 145.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Stock options

ESPP

401k

Onsite gym

Paid time off

Descripción de la vacante

Pulse Biosciences, Inc. is seeking a Principal Quality Engineer to lead quality systems (QSR 21 CFR 820; ISO 13485) for CellFX System, surgical disposables, and reusable medical devices.

You will guide product development and manufacturing with robust design controls, risk management, and traceability practices. Responsibilities include leading verification/validation, biocompatibility, sterilization validation, CAPA, and regulatory readiness, while partnering across R&D, manufacturing, and

Formación

• Bachelor’s degree in Engineering or related field.
• Minimum 10+ years as a Quality Engineer in Class III/II medical devices.
• Extensive experience with FDA QSR and ISO 13485/MDR requirements.

Responsabilidades

• Provide guidance on design controls and compliance for product development and manufacturing.
• Develop and maintain quality engineering systems meeting regulatory requirements.
• Lead risk management, traceability, and verification/validation activities.
• Manage biocompatibility testing, sterilization validation, and packaging validation.
• Support regulatory audits and prepare submissions.

Conocimientos

Quality engineering

Regulatory compliance

Risk assessment (ISO 14971)

Design control

Traceability

Biocompatibility

Sterilization validation

CAPA management

Statistical analysis

FDA QSR (21 CFR Part 820/Part 11)

Educación

Bachelor’s degree in Engineering

Herramientas

MS Office

Descripción del empleo

Pulse Biosciences, Inc. is seeking a Principal Quality Engineer to lead quality systems (QSR 21 CFR 820; ISO 13485) for CellFX System, surgical disposables, and reusable medical devices.

You will guide product development and manufacturing with robust design controls, risk management, and traceability practices. Responsibilities include leading verification/validation, biocompatibility, sterilization validation, CAPA, and regulatory readiness, while partnering across R&D, manufacturing, and