Senior Design Quality Engineer

Roles & Responsibilities

• Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
• Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
• Leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
• Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
• Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
• Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
• Leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
• Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)

Education & Experience

• 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
• Strong hands-on experience with design controls, DHF management, and traceability in regulated environments
• Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
• Experience supporting software quality within the SDLC and understanding of software risk management principles
• Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
• Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
• Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
• Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes
• 10+ years of experience in software quality assurance within regulated environments (medical device preferred)
• Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements
• Proven experience reviewing and improving SOPs or quality processes for regulatory compliance
• Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814)
• Experience with test management, defect tracking, and quality documentation tools
• Strong analytical, documentation, and stakeholder communication skills with ability to influence quality decisions
• Bachelor's degree in Engineering (Biomedical, Software, Systems) or a related technical discipline
• Advanced degree (Masters) in Engineering, Quality, or Regulatory Affairs preferred
• Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus