Senior Design Quality Engineer - Materials & Risk

Dexcom Inc.; San Diego (CA); On-site; USD 129,000 - 214,000; Full time

Benefits offered by this job

Comprehensive benefits program

Global career growth opportunities

Career development programs

Job summary

Dexcom Inc. designs, develops, and delivers CGM technology. The Design Quality Engineering team leads material characterization, qualification strategies, and risk management across advanced technology and lifecycle programs.

You will partner with R&D, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs to ensure decisions are evidence-based and compliant. You will work primarily from a home office, traveling 0–5% as needed, with a strong emphasis on ISO 14971 risk

Qualifications

• Bachelor's degree in a technical discipline; 13+ years experience or MS with 8+ years, PhD plus 5+ years in related field.
• Experience characterizing and qualifying complex material systems (polymers, enzymes, reagents, coatings, etc.).
• Experience applying ISO 14971 risk management to establish traceability between material attributes and product risks.

Responsibilities

• Act as SME for material characterization, qualification strategies, and risk management for materials across product lifecycle.
• Lead quality oversight of material attributes, formulations, and finished materials with a focus on polymers, enzymes, reagents, adhesives, coatings, membranes.
• Partner with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs to base decisions on robust evidence.
• Drive risk-based decisions and ensure traceability between material attributes, critical quality attributes, and product risks.
• Provide leadership for characterization studies, analytical method assessments, stability programs, and verification activities.

Skills

material characterization

analytical chemistry

formulation development

material science

ISO 14971 risk management

design controls

verification and validation

cross-functional collaboration

risk-based decision making

regulatory submissions

Education

Bachelor's degree in Chemistry/Engineering/Materials Science

MS or PhD preferred

Tools

Analytical methods

Job description

Dexcom Inc. designs, develops, and delivers CGM technology. The Design Quality Engineering team leads material characterization, qualification strategies, and risk management across advanced technology and lifecycle programs.

You will partner with R&D, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs to ensure decisions are evidence-based and compliant. You will work primarily from a home office, traveling 0–5% as needed, with a strong emphasis on ISO 14971 risk