Senior Design Quality Engineer

📋 Description

• Guide design quality from early concept through commercialization and design transfer
• Own or contribute to design-control and risk-management execution across product development
• Develop and review risk-based verification and validation strategies
• Drive quality readiness for design transfer and commercialization
• Lead or support product risk-management activities
• Support Regulatory Affairs with submissions, responses, and audits

🎯 Requirements

• Bachelor’s degree in electrical engineering, mechanical engineering, systems engineering
• 6+ years in quality engineering, including 4 years in medical-device design and development
• 3+ years applying design controls and risk management, including experience with electromechanical
• Experience with software as a medical device (SaMD) and software in a medical device (SiMD)
• Experience navigating a quality management system with minimal oversight
• Experience coaching, mentoring, or teaching engineering teams in design quality, data analysis

🎁 Benefits

• Comprehensive medical, dental, and vision coverage
• Traditional or Roth 401(k) with 2% company match
• Modern life stipends for learning and development
• Discounted company stock through ESPP