Senior Design Quality Engineer – Materials & Risk

1 DexCom Inc; San Diego (CA); À distance; USD 129 000 - 214 000; Plein temps

Avantages offerts par ce poste

Front row CGM tech

Community: dexcomwarriors

Comprehensive benefits

Global growth opportunities

In-house learning programs

Tuition reimbursement

Résumé du poste

Dexcom is seeking an experienced Design Quality Engineer specializing in material characterization and risk management to support advanced technology and lifecycle programs. You will lead material-related quality activities, collaborate with multiple functions, and ensure robust evidence-based decisions in a regulated environment.

You will drive risk-based decision making using ISO 14971, ensuring traceability from material attributes to device safety and performance, while representing Design

Qualifications

• Minimum 8 years of experience in medical device, pharmaceutical, biotechnology, or combination product development and quality engineering roles.
• Bachelor's degree in a technical discipline; MS/PhD preferred.
• Experience characterizing and qualifying complex material systems (polymers, enzymes, reagents, adhesives, coatings, membranes).
• Strong cross-functional collaboration and communication skills; ability to influence in multidisciplinary teams.

Responsabilités

• Lead quality oversight for material characterization and qualification strategies across raw materials, intermediates, formulations, and finished materials.
• Establish traceability between material attributes, formulation characteristics, manufacturing processes, and device safety/performance.
• Collaborate with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs.
• Apply ISO 14971 risk management to identify, evaluate, control, and verify material-related hazards and risks.
• Provide leadership for characterization studies, analytical method assessments, stability programs, and verification activities; support design reviews and regulatory submissions.

Connaissances

Material characterization

Analytical chemistry

Formulation development

Material science

Formation

Bachelor's degree in Chemistry, Chemical Engineering, Materials Science, Polymer Science, Biochemistry, Biomedical Engineering, Pharmaceutical Sciences, or related

Advanced degree (MS or PhD) preferred

Description du poste

Dexcom is seeking an experienced Design Quality Engineer specializing in material characterization and risk management to support advanced technology and lifecycle programs. You will lead material-related quality activities, collaborate with multiple functions, and ensure robust evidence-based decisions in a regulated environment.

You will drive risk-based decision making using ISO 14971, ensuring traceability from material attributes to device safety and performance, while representing Design