Engr I, Software Quality - Failure Analysis

About the Role

Key Responsibilities

• Investigate software-related complaints by analyzing system logs, user reports, and product performance data.
• Perform root cause analysis and collaborate with software development teams to identify corrective and preventive actions.
• Generate comprehensive failure investigation reports to support findings, root cause, regulatory requirements, and obtain the necessary approvals.
• Support risk management activities by assessing software-related failures and their potential impact on patient safety.
• Initiate discussions with management and QA when new failure mode(s) is(are) identified during failure analysis.
• Participate in Corrective Action/Preventive Action (CAPA) process as a CAPA owner or in a supporting role that includes the investigation of failures.
• Provide frequent verbal and written updates of work-in-progress for various meetings.
• Work closely with cross-functional teams to drive improvements in software quality, usability, and regulatory compliance.
• Assist in developing and maintaining complaint-handling procedures for software-related issues.
• Participate in software validation and verification activities to enhance product reliability.
• Ensure compliance with medical device regulations, such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
• Contribute to post-market surveillance and trending analysis for software-related complaints.

Requirements

• Bachelor's Degree in Engineering with no experience required or Master's Degree or equivalent in Engineering or Scientific field with no experience required.
• Previous experience working with Software (preferred).

Nice to Have

• Experience with embedded systems and cloud-based medical software.
• Knowledge of software development life cycle (SDLC) and agile methodologies.
• Understanding of post-market surveillance requirements and complaint handling processes.
• Strong understanding of medical device regulations (FDA, ISO 13485, IEC 62304, and ISO 14971).
• Proficiency in software debugging, log analysis, and defect tracking tools.
• Familiarity with software validation and verification in regulated environments.
• Strong analytical, problem-solving, critical thinking, and communication skills.
• Ability to work independently and in cross-functional teams to resolve complex issues.
• Basic documentation, communication, and interpersonal relationship skills.
• Basic understanding of statistical techniques.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.

Qualifications

• Bachelor's Degree in Engineering or Scientific field
• Master's Degree or equivalent in Engineering or Scientific field

Benefits & Perks

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs