Junior Design Quality Engineer

该职位来源于猎聘 Who We Are Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications.We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including:Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medtronic, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery. About The Team Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on,technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together! This position provides hands-on technical guidance and leadership from a Quality perspective to the team throughout all stages of product development up to and including technology transfer and commercialization. We are looking for someone that is highly motivated and solution oriented; you must be a self-starter, good team player, and excellent communicator. This is a Full Time Salaried position. A Day In The Life Of Our Junior Design Quality Engineer - SW Provide hands-on guidance for non-product Software programs follow theprocess of Computerized Software Validation and others. Participate in thedesign development process of non-product software. Review and control the non-product software quality for the R&D, IT, Manufacturing organization and ensure the execution of the strategy. Review verification plans, and verification procedures based upon the non-product software requirements ensuring that appropriate statistical techniques are applied. Support the development and implementation of quality processes for non-product software, including risk management,validation, and documentation. Assist in creating and maintaining non-product software quality plans, protocols, and reports in alignment with company procedures and regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485). Participate in software validation activities, including requirement analysis, test case development, and execution of validation protocols. Collaborate with cross-functional teams (R&D,IT, Manufacturing) to ensure software tools meet quality and compliance requirements. Support both internal and external audits related non-product software. Assist in investigating and documenting software-related issues, non-conformances, and corrective/preventive actions (CAPA). Work collaboratively and efficiently in a fast-paced environment with minimal supervision and guidance. Stay updated on industry trends, regulatory changes, and best practices in software quality engineering. Other QMS activities not specified here and as assigned. About You BS in Computer Science, Software development or other related major. Minimum of 2 years of Design Quality Engineering work experience in the medical device, experience in non-product software design development quality experience. Familiar with Non-product GxP related software applications (i.e. eQMS, ERP, production quality control software application, off-the-shelf software, embedded software, firmware,SaaS, and hardware/software integration that may indirectly impact product quality. Familiar with the process of development, implementation,maintenance, and retirement of GxP related applications and tools. Automation Testing Tools: QTP/UFT, Load Testing tools (LoadRunner and Web Performance Load Tester) Microsoft TFS and MS Visio. Analyzed business/technical requirements and developed test plans Created manual/automation test cases Trained junior testers on test script execution Maintained automated scripts for functional testing Executed performance testing using LoadRunner/Web Performance Load Tester Performed end-to-end application testing and database validation Documented defects and coordinated resolution with developers Generated test performance reports. An all-English working environment, good at speaking and writing. Prefer: Experience with software testing tools and methodologies. Knowledge of programming languages (e.g., Python,Java, C++) or scripting tools. Exposure to risk management frameworks (e.g., ISO14971). Familiar with NC/INV/CAPA process, complaint handling process.