Quality Systems Engineer – Medical Devices & Risk

Healy World; San Francisco (CA); Sur place; USD 110 000 - 165 000; Plein temps

Résumé du poste

Nudge is seeking a Quality Systems Engineer to ensure our devices meet safety and regulatory requirements. You will lead quality discussions, drive changes across design controls, investigations, and clinical trials involvement where needed.

Ideal candidates have at least 2 years of relevant experience, strong technical writing, and familiarity with GCP, ISO standards, and FMEA-driven risk management. Join a mission-driven team shaping brain interface technology.

Qualifications

• Minimum 2 years of quality systems engineering experience.
• Experience with design controls, validation, and risk management.
• Familiarity with GCP, FDA QMSR, ISO 13485, and ISO 14971.
• Experience conducting risk management using FMEA.
• Strong technical writing and communication abilities.

Responsabilités

• Ensure all product designs and processes meet safety and regulatory requirements.
• Lead quality discussions and drive necessary process changes across design controls and trials.
• Manage multiple tasks and drive change orders to completion.
• Lead CAPA investigations and implement mitigations.
• Collaborate with interdisciplinary teams to uphold high quality standards.

Connaissances

Design controls

Product/process validation

Risk management

Technical writing

Integrity & judgement

Formation

Engineering or scientific degree

Outils

FMEA

Description du poste

Nudge is seeking a Quality Systems Engineer to ensure our devices meet safety and regulatory requirements. You will lead quality discussions, drive changes across design controls, investigations, and clinical trials involvement where needed.

Ideal candidates have at least 2 years of relevant experience, strong technical writing, and familiarity with GCP, ISO standards, and FMEA-driven risk management. Join a mission-driven team shaping brain interface technology.