Senior Software Quality Assurance Engineer

2 days ago


Warren, Maine, United States Joulé Full time

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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