Senior Software Quality Assurance Engineer
2 days ago
Job Summary:
We are seeking a Senior Software Quality Assurance Engineer to lead our efforts in agile development environments, manage root cause analyses, oversee design control processes, and validate critical methods impacting device functionality.
About Joulé:
Joulé is a leading provider of medical devices. Our mission is to provide innovative solutions that improve patient outcomes.
Salary and Benefits:
The salary for this role is $123,600 - $154,500 per year, with a 10% bonus. We also offer a comprehensive benefits package, including multiple group medical, dental, and vision plans, a robust wellness program, life insurance, disability coverages, and a variety of voluntary programs.
Key Responsibilities:
- Collaborate with cross-functional teams to ensure product design meets both regulatory standards and customer needs
- Evaluate Design and Development deliverables to ensure high-quality products meet customer needs
- Support SW development improvements in agile environments while complying with medical device regulations
- Anticipate roadblocks and provides direction for navigating the quality system
- Ensure thorough root cause analysis for design changes or validation failures
- Translate critical design attributes to design outputs
- Guide major programs and may take on project leadership roles
Requirements:
- 8 years of experience, including 3-4 in medical devices (quality for design and development in R&D or quality)
- Bachelor of Science degree or Master of Science degree in Engineering or computer science preferred
- Strong in design quality for embedded medical device software or software development for devices
- Understanding of software functionality
- Experienced in risk management and product development as a development or design quality engineer
- Familiar with software development and agile methodologies
- Knowledge of 21 CFR 820.30, ISO 13485, ISO 14971, and ISO 62304
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