Sr. Software Design Quality Engineer

Title: Sr. Software Design Quality Engineer
Location: Plano, TX (100% Onsite)
Duration: 6

Months(Possibility of Extension)
Shift Time: 8:00am to 5pm
Pay Range: $45/hr to $50/hr (On W2)

We are looking for a “Sr. Software Design Quality Engineer“ to join one of our Fortune 500 clients.

Job Summary:

This onsite role is based in Plano, TX, supporting the Neuromodulation division. Our products involve implantable Class III medical devices and integrated software ecosystems that improve quality of life for patients suffering from chronic pain and movement disorders.

As a Design Quality Engineer, you will serve as a quality champion within product development, ensuring that system designs meet the highest standards of patient safety, product reliability, regulatory compliance, and clinical effectiveness. You will drive adherence to global regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and EU MDR.

Job Responsibilities:

• Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical device systems.
• Ensure all product development activities comply with design control requirements and align with patient safety and clinical performance objectives.
• Review and approve requirements, design, development and verification/validation deliverables in compliance with FDA QSR requirements and applicable ISO/IEC standards.
• Ensure compliance with IEC 62304 software lifecycle processes, including software safety classification, Software development planning, requirements, architecture, detailed design, integration testing, system and software level verification, maintenance, and issue resolution.
• Support design control deliverables for new product development, Software/firmware changes, Cybersecurity related updates.
• Evaluate software risk controls and ensure traceability between hazards, requirements, risk mitigations, and verification evidence.
• Lead Risk Management activities (ISO 14971) including risk management plan/report, hazard analysis and failure mode effects & criticality analysis (FMECAs).
• Ensure continuous risk acceptability through analysis of post market data and clinical feedback.
• Support product development equipment qualification activities, inspection method development and validation activities.
• Apply risk based, structured problem solving to identify, prioritize, and resolve quality issues; participate in root cause investigations and drive effective corrective/preventive actions.
• Ensure integrity and completeness of the Design History File (DHF) and alignment with FDA Quality System Regulation (QSR) and ISO 13485 requirements.
• Accountable for Applicable Standards Document & checklists, Labeling Verification planning & execution, Essential Output reports, and General Safety and Performance Requirements (GSPR).
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Education:

• Bachelor’s Degree in Engineering, Technical field OR an equivalent combination of education and work experience.
• 5+ years of design quality experience in a regulated industry and demonstrated use of quality tools/methodologies (medical devices experience preferred).
• Experience with verification/validation practices, and risk based quality engineering.
• Experience with software development life cycle (IEC 62304), verification/validation practices, and risk based quality engineering.
• Working knowledge of cybersecurity requirements, software configuration management, and requirements management tools (e.g., Polarion, Doors, Jira).
• Strong understanding of ISO 14971, ISO 13485, FDA 21 CFR Part 820 design control principles.
• Strong analytical/problem solving with proven ability to assess technical information, challenge design decisions objectively, and ensure compliance.
• Excellent communication, critical thinking, and cross functional collaboration skills.
• Advanced computer skills, including statistical/data analysis and report writing skills.

Preferred Qualifications:

• Master’s Degree in Engineering or Technical Field.
• Experience with implantable Class III medical devices or safety critical embedded systems.
• Experience with data driven problem solving, statistical analysis, or reliability engineering tools.

We are looking for the candidate who are eligible to work with any employers without sponsorship
.

If you’re interested, please click “Apply” button