Senior Quality Engineer

A medical device organization is seeking a Senior Quality Engineer to serve as a key technical leader and partner to quality and engineering leadership. This individual will play a critical role in shaping product quality strategy, with a strong emphasis on design evaluation, risk assessment, and influencing engineering decisions
.

This is a high-impact position for someone who can operate as a trusted advisor and mentor
, bringing deep mechanical and design perspective into quality while helping elevate team capability and processes.

• Act as a senior technical partner to leadership, supporting complex quality and design-related decisions
• Mentor and guide junior engineers, serving as a go-to resource for best practices and problem solving
• Lead and influence key quality activities across product development, including: DFMEA / PFMEA, Risk analysis and mitigation strategies, Design change evaluation and decision support
• Collaborate cross-functionally with engineering, manufacturing, and supply chain to drive product quality improvements
• Translate design risks and FMEA outputs into clear, actionable insights
• Support development and continuous improvement of quality systems and processes (QMS)
• Apply Six Sigma and continuous improvement methodologies to enhance consistency and performance
• Communicate complex technical concepts effectively to a broad range of stakeholders

• Bachelor's degree in engineering (mechanical preferred) with 6+ years of relevant experience
• Background in mechanical design, design engineering, or design assurance
  , with exposure to quality engineering
• Strong expertise in design-focused quality principles
  , not just testing or validation
• Hands-on experience with: DFMEA / PFMEA, Risk analysis, root cause investigation, and design controls, Change management within product development environments
• Ability to evaluate designs and guide others
  , rather than focusing on test execution
• Proven experience mentoring or influencing engineers across teams
• Familiarity with medical device regulations and standards (e.g., FDA, ISO) preferred