Senior Software Quality Engineer

About the role

An innovative and rapidly growing medical device organization is seeking a Senior Software Quality Engineer to play a critical role in ensuring the quality, compliance, and successful release of software products supporting both medical device applications and manufacturing operations. This position offers the opportunity to work closely with cross-functional teams across product development, quality, regulatory, and engineering while helping bring life-changing technologies to market. This is an opportunity to join a well-established medical device innovator developing technologies that positively impact patients around the world. You'll work alongside accomplished engineering, quality, and regulatory professionals while helping shape the quality strategy for critical software products and future innovations. If you are passionate about medical device software quality, regulatory compliance, and partnering with development teams to deliver safe and effective products, we'd love to connect.

Responsibilities

• Lead quality engineering activities supporting Software as a Medical Device (SaMD), quality system software, and manufacturing software platforms.
• Provide expertise throughout the software development lifecycle, including design controls, risk management, verification and validation, maintenance, and change management.
• Partner with engineering and product development teams to ensure the compliant and efficient release of software products.
• Drive software quality initiatives through risk assessments, investigations, root cause analysis, CAPA activities, and continuous improvement efforts.
• Review and approve design control documentation, validation strategies, and quality deliverables for new product development programs.
• Support software nonconformance investigations, customer complaint assessments, and technical troubleshooting efforts.
• Provide leadership in quality system compliance and regulatory requirements within a highly regulated medical device environment.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical field.
• 5+ years of experience in software quality engineering, validation, design controls, or quality assurance within the medical device industry.
• Strong understanding of FDA Quality System Regulations and ISO 13485.
• Experience supporting software change management processes.
• Working knowledge of medical device software standards, including IEC 62304 and IEC 82304.
• Experience with