Senior Process Development Engineer

DexCom • San Diego, CA

7d

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 Senior Process Development Engineer develops, qualifies, validates, and manages changes to complex manufacturing automation equipment and works with cross-functional teams to integrate technology into manufacturing processes. The role supports efficiency, precision, and quality, as well as new product development, capacity expansion, and sustained on-market performance.

The engineer contributes to process development and design control for medical devices, with an emphasis on design transfer and the relationship between system design, technical and business requirements, failure modes, and process controls. The role also supports validation of process performance and product quality and transfer of technical deliverables through the quality management system. Dexcom describes its mission as improving human health through biosensing technology and continuous glucose monitoring solutions.

Requirements

• Bachelor’s degree in a technical discipline; the posting identifies Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field as relevant.
• Typically, 5–8 years of related experience with a bachelor’s degree, 2–5 years of equivalent industry experience with a master’s degree, or 0–2 years of experience with a PhD.
• 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: plastic component assembly; needles; adhesives, epoxies, and curing; or packaging, including sterile barrier, secondary, or tertiary boxing.
• Ability to communicate effectively and create PowerPoint presentations to deliver objectives and outcomes from technical teams through executive leadership.
• Cross-functional collaboration experience with peers and leaders.

Nice To Haves

• Master’s degree preferred.

Responsibilities

• Participate in new product process development, design of experiments, and measurement system analyses; collect and analyze data against program process development targets.
• Execute design control activities, with emphasis on 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, including the protocols and reports needed 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