Senior Quality Engineer for Medical Devices
3 weeks ago
The Role
We are seeking a highly skilled Principal Instrumentation Software Test Engineer to lead the development and implementation of comprehensive testing strategies for our advanced medical devices. This role requires a strong background in software testing, quality assurance, and problem-solving in complex systems.
Key Responsibilities:
- Test Planning & Execution: Develop detailed software testing plans and scripts based on product specifications, incorporating advanced testing methodologies (e.g., regression, functional, integration, and system testing). Conduct hands-on testing, including validation and performance testing, to ensure compliance with design and regulatory standards.
- Complex Problem Solving: Facilitate technical problem-solving and troubleshooting for software and instrumentation challenges. Lead root cause analysis and provide engineering solutions, making independent decisions on critical issues.
- Project Leadership & Cross-functional Collaboration: Lead or participate in cross-functional technical teams, collaborating closely with Software, Customer Technical Support, Service, and other departments to deliver high-quality instrumentation systems that align with Roche's product portfolio and strategic objectives.
- Data Analysis & Insight Generation: Design and conduct experiments to validate hypotheses, analyze technical data, and provide actionable insights for product improvement.
- Documentation & Compliance: Ensure detailed and organized documentation for all testing activities, adhering to GLP, GMP, and regulatory standards. Lead configuration control, maintain secure documentation, and support quality-first initiatives in compliance with industry and company standards.
- Experience: Significant experience as a Software Test Engineer, preferably in a regulated industry such as medical devices, with expertise in testing and validation, quality assurance, and problem-solving in complex systems.
- Technical Skills: Proficient in a wide array of testing techniques (e.g., system, regression, integration, load testing) and software testing tools such as DevTrack and TestLink. Expert knowledge in SW planning, integration, and configuration management.
- Personal Qualities: Analytical, diligent, and proactive. Strong communication skills to present complex technical data effectively. Adaptable to a fast-paced environment with a focus on quality and continuous learning.
About the Company
F. Hoffmann-La Roche Ltd is a global leader in the pharmaceuticals and diagnostics industries. We are committed to making a positive impact on people's lives through our innovative products, services, and solutions.
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