Software Design Quality Engineer

🚨 Hiring | Software Design Quality Engineer | Plano, TX (Onsite) | Contract A contract opportunity is available for an experienced Software Design Quality Engineer with strong expertise in medical device design controls, risk management, and software quality engineering. 📍 Location: Plano, TX (Onsite Only) 📄 Employment Type: Contract 🏥 Industry: Medical Devices ⸻ 🔎 Role Overview The Software Design Quality Engineer will support design and development quality activities for new product development, design changes, and clinical programs within regulated medical device environments. ⸻ 🔑 Key Responsibilities • Support Design Control processes including Design Inputs, Outputs, Verification, and Validation • Review and approve Design History Files (DHF) and software-related deliverables • Compile technical documentation for regulatory submissions (510(k), CE Mark) • Lead and maintain Risk Management Files in alignment with ISO 14971 • Develop and maintain Hazard Analysis, SFMEA, DFMEA, UFMEA, and Risk Management Reports • Support equipment qualification, inspection methods, and test validation activities • Collaborate with cross-functional teams across engineering, regulatory, and quality • Ensure compliance with ISO 13485, FDA regulations, and EU MDR ⸻ 🧠 Required Qualifications • 6+ years of medical device design/development quality experience • Strong experience supporting New Product Development (NPD) programs • Experience with implantable Class III medical devices or safety-critical embedded systems • Knowledge of software development lifecycle (IEC 62304) • Experience with Design History Files and Technical Documentation • Strong understanding of ISO 13485, FDA, and EU MDR regulations • Strong analytical, problem-solving, and communication skills ⸻ ⭐ Preferred Skills • Experience with cybersecurity requirements in medical devices • Familiarity with requirements and configuration management tools such as Polarion, DOORS, or Jira ⸻ 📩 Recruiting Contact: Mohd Shariq – Technical Recruiter 📧 [Upgrade to PRO to see contact] 📞 +1 (408) 459-7161 ⸻ #Hiring #MedicalDeviceJobs #DesignQuality #IEC62304 #ISO13485 #ISO14971 #DesignControls #QualityEngineering #PlanoTX