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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Design Quality Engineer - Medical Devices - Durham, NC - **Company:** Gilero, LLC - **Location:** Durham, NC, United States - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Failure Mode Effects Analysis, Integrated Development Environments, Software Requirements Analysis, Verification and Validation (Software), Iq/oq/pq, GXP - **Published:** October 23, 2026 - **Apply:** https://www.thejobnetwork.com/job/943f77c8-642e-4ec4-99c9-0d49ab846300/senior-design-quality-engineer-medical-devices-durham-nc ## About the Role * Able to work in the office at least 3 days a week * Bachelor's degree in engineering, science, or relevant field * 5+ years relevant work experience * Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and/or combination product development and manufacturing * Proficiency with ISO 14971 and application of risk management to the development of medical devices and/or combination products * Experience with electromechanical medical devices and IEC 60601 preferred * Strong preference for experience in pharma or medical device manufacturing and/or development environment; Strong preference for electromechanical systems based experience * Experience using risk analysis and continuous improvement concepts * Experience with GxP requirements * Experience supporting audits * Strong technical written and verbal communication skills * Excellent interpersonal, change management, planning, and organizational skills * Excellent oral, written, and presentation communication skills Personal Attributes: * Meets Gilero Core Values: Collaboration and Innovation of Excellence and Integrity * Productive in a fast-paced, entrepreneurial environment. * Commits to excellence and quality service to external and internal customers. * Adheres to established policies and procedures, while contributing to continuous improvements. ## Description Are you passionate about using cutting-edge technology to improve lives? As a Senior Design Quality Engineer at Gilero, A Sanner Company, you'll play a crucial role in ensuring the quality development of new medical device and combination products; from ideation through transfer to manufacturing. You will be responsible for quality oversight of the design, development, and production of medical devices and combination products with a focus in the areas of risk mitigation, requirements definition, and verification and validation strategy and implementation. Join us in a collaborative and innovative environment where your contributions will make a real difference on impacting the lives of patients and health care providers. You'll work with multiple disciplines and clients across a wide variety of products to help shape the future of healthcare technology, ensuring products meet the highest standards and positively impact patient outcomes across the globe., * Represent Quality in cross-functional development teams, providing direction for development through transfer to production activities. * Author, maintain, and ensure compliance of Design History File documents during the development process in accordance with ISO 13485. * Translate user needs, intended use, regulatory inputs, and risk controls into measurable product requirements, specifications, and acceptance criteria. * Support design verification and validation activities, including statistical approach and analysis * Support project related efforts with quality system elements (CAPA, Complaints, Supplier Management, External Audits, etc.). * Participate in and facilitate risk management activities (hazard analysis, FMEAs, and risk assessments per ISO 14971) * Ensure traceability and testability of design requirements and risk controls. * Support manufacturing transfer, including review of preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans. * Investigate, disposition, and resolve nonconforming material events during product development And pre-production phases; support production phases for transferred programs as needed. * Act as technical expert (including potential author) for new or revised QMS procedures; May include train team members, and release quality system procedures, as required. * Support internal and external audits (particularly for projects), as required with help of broader quality management team * Support supplier selection, qualification, and ongoing monitoring with help of broader quality management team. * Facilitate investigations to determine root cause and failure modes. * Execute quality event initiation, investigation, and closure for nonconformances, CAPA, change control, and complaints as required.