Software Quality Assurance Engineer II
$78,540–$107,000 year
On-siteEden Prairie, Minnesota, United States
Job Summary
Lead software quality assurance and compliance by applying design controls throughout the product lifecycle, from advanced development to manufacturing. Ensure software and firmware adhere to international standards like IEC 62304 and ISO 13485 while partnering with research, development, and regulatory teams. Define test strategies, validate non-product systems using a risk-based approach, and maintain inspection-ready documentation for audits. Collaborate with design engineering to establish quality requirements and communicate project issues timely. Support cross-functional teams in implementing operational tools to improve product quality and efficiency.
Required Qualifications
- 5 years of software development or quality assurance
- knowledge of IEC 62304
- knowledge of ISO 13485
- At least a 4-year college degree (M.S. preferred) in Computer Science/Software/Electrical/Electronic Engineering
- Knowledge of Software development lifecycle principles
- Knowledge and understanding of software design, architecture and development
- Excellent analytical and problem-solving skills
- Excellent people skills
- Strong collaboration skills
- Strong written and oral communication skills
- Enough judgment to make reasonable business decisions concerning quality issues with regard for both economic and quality aspects
- Less than 5% travel
Desired Qualifications
- M.S. degree
- Experience with Operations, Customer Service, Sales, and/or Marketing business functions
- Experience testing application integration functionality
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