Sr Design Assurance Engineer (Software Medical Devices)

Position Summary

Lead quality and compliance activities for the development of innovative medical devices with embedded and standalone software. Serve as a subject matter expert in Design Controls, Risk Management, Human Factors, Software Lifecycle Processes, and Cybersecurity, ensuring products meet regulatory, quality, and customer requirements from concept through commercialization.

Key Responsibilities

• Provide Quality Engineering support for new product development, design changes, and OEM projects.
• Lead Design Control, Verification & Validation, and Risk Management activities.
• Develop and review quality plans, validation plans, design documentation, traceability matrices, and risk assessments.
• Ensure compliance with IEC 62304, IEC 60601, IEC 62366, ISO 14971, FDA, and ISO 13485 requirements.
• Analyze quality metrics, identify trends, and drive continuous improvement initiatives.
• Lead root cause investigations, CAPA activities, and problem-solving efforts.
• Partner with R&D, Regulatory Affairs, Manufacturing, and external stakeholders to achieve project and quality objectives.
• Present quality and compliance updates to leadership and project teams.

Required Qualifications

• Bachelor's degree in Engineering or related technical discipline.
  
• 6+ years related experience required.
• Experience with Design Controls, Verification & Validation, and Risk Management within a regulated industry.
• Strong knowledge of medical device software and quality regulations.
• Proven experience with root cause analysis, CAPA, and continuous improvement methodologies.
• Excellent communication, collaboration, and leadership skills.

Preferred Skills

• Expertise in medical device software development and cybersecurity.
• Hands-on experience with IEC 62304, IEC 60601, IEC 62366, and ISO 14971.
• ASQ CQE, CSQE, or other relevant quality certifications.
• Experience supporting global product development teams and regulatory submissions.
• Strong project leadership and cross-functional influencing skills.

Work Environment

• Collaborative, cross-functional environment working with Quality, R&D, Manufacturing, and Regulatory teams.
• Primarily office-based with occasional time spent in laboratory and manufacturing settings.
• Opportunity to influence product quality, patient safety, and innovation in healthcare.
  
  
  Salary Range: $92,215 - $115,300