Device Engineer II

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About the role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description   We are seeking a highly motivated, detail-oriented Device Engineer III to support drug-device combination products across the commercial lifecycle. The successful candidate will support commercialization and sustaining engineering activities for combination drug/medical devices, from design transfer through ongoing commercial support. This role requires expertise in design controls, risk management, change management, and complaint management.  Job Responsibilities   • Represent Device Development on commercial CMC and business continuity teams, and communicate technical findings and project updates clearly to project teams and stakeholders. • Implement post-launch changes, support complaint handling and investigations, and investigate and close out deviations. • Perform risk management reviews and updates in accordance with ISO 14971. • Maintain the Design History File (DHF) throughout the commercial lifecycle. • Support business continuity activities, including second sourcing. • Support manufacturing site selection and other late-stage development activities. • Execute design transfer activities to internal and external manufacturing sites. • Author, review, and approve technical documentation, including design control records, test methods, protocols, reports, and risk management documentation. Knowledge & Skills   • Candidates must have experience and knowledge in all of the following areas:  • Development and manufacturing of medical devices in accordance with ISO 13485.  • Risk management in accordance with ISO 14971.  • The candidate must have experience and knowledge in one or more of the following areas:  • Root cause analysis, deviation management, and investigations.  • Lifecycle change control management for combination products.  • Management of combination product-related complaints.  • Experience working with vendors, suppliers, and contract manufacturers to implement changes or investigate product and process performance issues.  • Design, execution, and statistical analysis of process characterization studies.  • Candidates with experience and knowledge in the following areas will be considered especially well qualified:  • Design transfer to internal and external manufacturing sites and partners.  • Familiarity with common mechanical assembly processes used in drug injection and delivery systems.  • Experience with Solidworks, Onshape, or Fusion 360.  • Familiarity with the requirements of ICH Q7, Q8, Q9, and Q10.  • Experience with project management methods and tools.  • Experience with basic statistical methods, including design of experi

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