Grenoble Medical Device Software Quality Engineer

Black Diamond Networks; Grenoble; Hybride; EUR 50 000 - 73 000; Plein temps

Résumé du poste

Black Diamond Networks is seeking a Software Quality Engineer to support a shoulder implant navigation software project in Grenoble. The role covers early prototype design, requirements, early labs, and execution of software quality deliverables across the lifecycle.

The candidate will collaborate with Testing/verification, Regulatory, Marketing and Hardware teams to ensure quality, with emphasis on process, risk management, and compliance for FDA submissions and eventual launch.

Qualifications

• Must-have: software quality experience in the medical device industry.
• Experience with SDLC in regulated medical devices, beyond test execution.
• Knowledge of software quality risk management.
• Experience creating and maintaining RTM.
• Experience with Software FMEA (FMEA).
• Able to communicate with software developers and speak their language.

Responsabilités

• Support software development lifecycle from early design through verification and launch.
• Contribute to quality documentation for FDA 510(k) submission and launch.
• Participate in dry runs and software testing coordination with focus on process and quality.
• Perform software quality risk management activities, including RTM and FMEA.

Connaissances

Medical devices

SDLC experience

RTM

FMEA

Regulatory

Cross-functional

Description du poste

Black Diamond Networks is seeking a Software Quality Engineer to support a shoulder implant navigation software project in Grenoble. The role covers early prototype design, requirements, early labs, and execution of software quality deliverables across the lifecycle.

The candidate will collaborate with Testing/verification, Regulatory, Marketing and Hardware teams to ensure quality, with emphasis on process, risk management, and compliance for FDA submissions and eventual launch.