Sr. Manager, Software Design Quality Engineering

Sr. Manager, Software Design Quality Engineering

Location: Burlington, MA

As a Senior Manager in Software Quality, you will lead a team of engineers dedicated to ensuring the development of safe, effective, and compliant software solutions. This role oversees quality assurance for cloud-based, mobile, and embedded software platforms, with a strong emphasis on regulatory compliance, cybersecurity, and continuous improvement.

Key Responsibilities

• Lead, mentor, and develop a high-performing team of software quality engineers.
• Drive enhancements in software design controls to support evolving technologies and regulatory requirements.
• Collaborate with cross-functional teams, including Product Security, to strengthen cybersecurity and data integrity practices.
• Provide oversight for software development lifecycle (SDLC) deliverables, including requirements, risk management, verification & validation, defect tracking, and traceability.
• Ensure compliance with global regulatory standards, including FDA, ISO 13485, IEC 62304, EU MDR, and MDSAP.
• Support and improve quality system processes such as audits, CAPA, document control, training, and product release.
• Recruit and retain top talent while aligning team objectives with broader business goals.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
• Minimum 9 years of experience in medical device quality, regulatory affairs, or product development.
• At least 5 years of experience managing technical or quality-focused teams.
• Deep understanding of global medical device regulations and software development standards.