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

Location: Grenoble, FR (2-3 days onsite per week)

Duration: ~ 6-7 months

Time Commitment: 1.0 FTE

Target Start Date: Aug - Sept

Job Description: The client is seeking a software quality engineer to support a shoulder implant navigation software device project. The project is early in the software development lifecycle (prototyping, requirements, early labs) and the work will be focused on execution of software quality deliverables across the software development lifecycle

Key responsibilities:

• Support software development lifecycle from early design/prototyping and requirements through design freeze, verification, validation, and launch
• Contribute to quality documentation and deliverables needed for FDA 510(k) submission and subsequent launch
• Participate in dry runs and software testing coordination (emphasis on process and quality, not pure tester role)
• Perform software quality risk management activities, including:
• Creation and maintenance of Requirements Traceability Matrix (RTM)
• Software FMEA (Failure Modes and Effects Analysis)

Collaborate cross-functional with:

• Testing/verification
• Regulatory
• Marketing
• Hardware team members

*Most Important Skills Needed:

• Software quality experience within the medical device industry (must-have)
• Hands-on experience with software development lifecycle (SDLC) in regulated medical devices, beyond just test execution
• Software quality risk management
• Requirements Traceability Matrix (RTM)
• Software FMEA
• Experience working closely with software developers; ability to "speak their language"

Nice-to-have domain experience:

• Robotics in medical devices
• Cybersecurity related to medical device software