Staff Process Development Engineer

Dexcom • San Diego, CA

1d • $111,100 - $185,100

About The Position

Dexcom’s Global Engineering team within Operations provides end-to-end technical oversight of manufacturing technologies across suppliers, contract manufacturers, automation houses, and internal manufacturing, including technical support for on-market production. The Staff Process Development Engineer supports development, qualification, validation, and change management of complex manufacturing processes and automation equipment. The role works cross-functionally to integrate technology into manufacturing, ensuring efficiency, precision, and quality while supporting new product development, capacity expansion, and sustained production performance.

The position leads and supports new-product process development, design of experiments, and measurement system analyses; executes design-control activities with an emphasis on design transfer; reviews design changes and optimizes manufacturing processes for medical devices; uses statistical methods to analyze process data and implement controls; and develops and executes test methods and validation documentation. The engineer collaborates with R&D, Quality Assurance, Regulatory Affairs, Supply Chain, and Manufacturing to transfer technical deliverables through the quality management system.

Requirements

• Bachelor’s degree in a technical discipline and typically 8–12 years of related experience; alternatively, a Master’s degree and 5–7 years of equivalent industry experience, or a PhD and 2–4 years of experience.
• Degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• Understanding of experimental study design and measurement system analysis, including appropriate statistical approaches to data analysis.
• Understanding of medical device design transfer and knowledge of quality and regulatory standards.
• Experience in at least one of the following areas: plastic component assembly, needles, adhesives, epoxies and curing, or packaging (sterile barrier, secondary, or tertiary boxing).
• Ability to communicate effectively and create PowerPoint presentations that deliver objectives and outcomes to audiences from technical teams through executive leadership.
• Cross-functional collaboration experience with peers and leaders.

Nice To Haves

• Master’s degree.

Responsibilities

• Lead and support new product process development, design of experiments, and measurement system analyses to collect and analyze data against program process development targets.
• Execute design control activities, emphasizing design transfer and understanding system design, 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.
• Use statistical tools and methods to analyze process data, conduct capability studies, and implement process controls.
• Help develop and execute test methods, protocols, and reports to validate process performance and product quality.
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, Supply Chain, and Manufacturing to support business strategy and transfer technical deliverables within the quality management system.

Benefits

• Full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Career development through in-house learning programs and/or qualified tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior