Staff Process Development Engineer

Dexcom • San Diego, CA

28d

About The Position

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: You will be part of the Global Engineering team within Operations, tasked with end-to-end technical oversight of our manufacturing technologies spanning our suppliers, contract manufactures, automation houses, and internal manufacturing. Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for the development, qualification, validation and change management of complex manufacturing automation equipment, working closely in cross-functional teams to integrate cutting-edge technology into our manufacturing processes. You will ensure high efficiency, precision, and quality in Operations. You will play a pivotal role in ensuring robust new product introduction, capacity expansion, and sustained on-market performance. This crucial role supports Dexcom's thrilling growth trajectory in delivering essential, life-changing products to our valued customers. As part of this dynamic and highly effective team, you will collaborate closely across multiple functions, gaining broad exposure to our entire product life cycle. Where you come in: You are a global engineering lead, managing execution of program deliverables that focus on both design/process changes to existing on Market product as well as new product development. Deliverables span from proof of concept to pilot manufacturing, to global high volume commercial automation. You will lead process development strategy, design of experiments and measurement system analyses to collect and analyze applicable data relative to program process development targets. You lead design control activities with emphasis on design transfer and a clear understanding of system design and the linkage between technical and business requirements, design and process failure modes and process controls. You will review design changes and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvements. You will utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls. You will help develop and execute test methods with necessary protocols and reports to validate process performance and product quality. You will provide technical expertise in equipment selection, qualification, and validation, ensuring equipment meets performance and regulatory requirements. You will collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing to ensure seamless business strategy and transfer of technical deliverables in the quality management system.

Requirements

• degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field; Master's degree preferred
• strong technical understanding of experimental study design and measurement system analysis including the appropriate statistical approaches to data analysis
• robust understanding of medical device design transfer with knowledge of quality and regulatory standards
• experience in at least 1 of the following areas; Plastic component assembly, needles, adhesives, epoxies and curing, and packaging (sterile barrier, secondary, tertiary boxing)
• advanced communication skillset and can create and deliver concise status reports and presentations from the technical team up through executive leadership
• effective cross-functional collaboration experience amongst peers and leaders
• mentorship experience that allows you to guide junior engineers, fostering a culture of continuous learning and development within the team
• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience

Responsibilities

• managing execution of program deliverables that focus on both design/process changes to existing on Market product as well as new product development
• lead process development strategy, design of experiments and measurement system analyses to collect and analyze applicable data relative to program process development targets
• lead design control activities with emphasis on design transfer and a clear understanding of system design and the linkage between technical and business requirements, design and process failure modes and process controls
• review design changes and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvements
• utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls
• develop and execute test methods with necessary protocols and reports to validate process performance and product quality
• provide technical expertise in equipment selection, qualification, and validation, ensuring equipment meets performance and regulatory requirements
• collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing to ensure seamless business strategy and transfer of technical deliverables in the quality management system

Benefits

• A front row seat to life changing CGM technology.
• Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees