Senior Mechanical Design Engineer, Medical Device Quality

Regulatory Jobs; Versailles (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Regulatory Jobs seeks a Quality Engineer to lead efforts in identifying, planning, and conducting activities that improve or ensure quality in medical device design and manufacturing. You will collaborate with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance, and cost, serving as the SME in the quality department.

The role emphasizes cross-functional leadership, QMS development, and Six Sigma-driven process improvements supporting regulatory

Qualifications

• Bachelor's degree in engineering or related field (required).
• CQE, Six Sigma Black Belt and CRE certifications preferred.
• Experience in the medical device industry and understanding of medical device quality systems.
• Ability to influence and negotiate with all levels of an organization and lead change initiatives.
• Ability to establish and enforce quality standards aligned with regulatory requirements.

Responsibilities

• Ensures products and changes comply with regulatory agencies (FDA, ISO, UL, CSA).
• Creates and improves the QMS to ensure compliance with regulatory requirements.
• Drives product quality improvements with design, manufacturing, and supply chain.
• Acts as a technical lead and manages significant systems with strategic planning and risk mitigation.
• Formulates solutions to complex, ill-defined problems using feedback and collaboration.
• Communicates complex technical ideas through daily work, presentations, and workshops.
• Fosters cross-team communication and collaborates with leadership to align decisions with goals.
• Champions Six Sigma and drives standardization through continuous process improvement.
• Identifies and manages Six Sigma projects across quality and supplier domains.
• Provides coaching to engineers and supports audits and investigations.

Skills

Quality engineering

Six Sigma

Regulatory compliance

Cross-functional leadership

Problem solving

Education

Bachelor's degree in engineering or related field

Certified Quality Engineer (CQE)

Six Sigma Black Belt

Certified Reliability Engineer (CRE)

Job description

Regulatory Jobs seeks a Quality Engineer to lead efforts in identifying, planning, and conducting activities that improve or ensure quality in medical device design and manufacturing. You will collaborate with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance, and cost, serving as the SME in the quality department.

The role emphasizes cross-functional leadership, QMS development, and Six Sigma-driven process improvements supporting regulatory