Role: Senior Software Quality Engineer
Location: Irving, TX 75038
Duration: 12 Months
Shift Timings: 8 AM to 5 PM

We are seeking a highly skilled Senior or Lead Software Quality Engineer to provide software quality support for new medical device product development. The role involves activities and tasks associated with the software development lifecycle (SDLC) and FDA design controls in accordance with ISO 13485 standards. This is a fully onsite position in Irving, TX.

• Support software quality activities for new medical device product development.
• Ensure compliance with FDA design controls (820.30) and ISO 13485/ISO 14971 standards.
• Conduct software verification and validation, ensuring traceability to requirements and risk analysis.
• Manage defect reporting and software configuration management throughout the SDLC.
• Collaborate with cross-functional teams to support regulatory compliance and quality objectives.

• Bachelor's degree in engineering, a technical field, or an equivalent discipline.
• Preferred: Degree in software-related fields such as Computer Science.

• Minimum of 5 years of experience in medical device software development lifecycle (SDLC).
• Experience with FDA design controls and software quality engineering.
• Proven track record in software verification/validation, including traceability to requirements, risk analysis, and defect reporting.
• Experience in software configuration management.
• Preferably experience with In Vitro Diagnostics (IVD).

1. Medical Device SDLC Experience: At least 5 years of experience in the medical device software development lifecycle, preferably with In Vitro Diagnostics (IVD).
2. ISO Standards Compliance: Familiarity with ISO 13485 (Medical Device Quality Management Systems) and ISO 14971 (Medical Device Risk Management).
3. FDA Design Controls: Proficient understanding and application of FDA design controls (820.30).
4. Software Verification and Validation: Experience in software verification and validation processes.

• Onsite interviews are preferred.
• A preliminary phone screening interview may be conducted prior to any onsite interviews.