Senior Staff Software Quality Engineer

We have an immediate opening for a highly motivated, results-focused professional to join our team, and are growing our staff as a Senior Staff Quality Engineer. The Quality Engineer's primary responsibilities are to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, review design artifacts, participate in risk analysis activities, collaborate on product development deliverable documentation, support failure investigations, identify system issues, summarize findings and prepare reports for key quality metrics.

Requirements

• Bachelor’s degree in a relevant degree field such as engineering and 15 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls OR Master’s degree in a relevant degree field such as engineering and 10 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls
• Ability to travel up to 10%
• Experience applying Lean or Six Sigma methodologies to streamline software design control processes
• Experience championing cybersecurity initiatives within regulated medical device environments
• Consistent track record supporting hardware development and integrating hardware/software systems within design controls frameworks
• Great foundation in modern software development methodologies
• Experience thriving in iterative development environments such as Scaled Agile Framework (SAFe), particularly with SAFe certifications
• Comprehensive understanding of risk management principles and quality-by-design approaches

Benefits

• Comprehensive health insurance
• 401(k) matching
• Paid time off
• Life insurance
• Disability insurance