Sr. Software Design Quality Engineer

7-9 Years

This job is no longer accepting applications

Job Description

Define and implement reliability strategies and frameworks for software systems.
Collaborate with cross-functional teams to integrate quality and reliability engineering throughout the SDLC.
Lead risk management activities including DFMEA, hazard analysis, and traceability.
Design and maintain post-market monitoring and alerting solutions to proactively address issues.
Conduct root cause analysis and drive effective CAPA implementation.
Develop tools and automation for reliability testing and validation.
Ensure system availability through redundancy, failover, and recovery strategies.
Support audits, regulatory inspections, and compliance with IEC 62304, ISO 13485, and ISO 14971.
Mentor teams on best practices and foster a culture of continuous improvement.

Qualifications

Bachelor's/Master's degree in Mechanical Engineering, Biomedical Engineering, or related field.
7+ years of experience in software quality, reliability, or medical device development.
Strong knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA regulations.
Hands-on experience with software risk management, verification/validation, and automation tools.
Excellent problem-solving, communication, and collaboration skills.