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.
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