Senior Design Quality Engineer - Material Risk & ISO 14971

1 DexCom Inc; San Diego (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Dexcom is seeking an experienced Design Quality Engineer specializing in material characterization and risk management to support advanced technology and lifecycle programs.

You will drive risk-based decision making using ISO 14971, ensuring traceability from material attributes to device safety and performance, while collaborating with multiple functions in a regulated environment to deliver robust evidence-based decisions.

Qualifications

• Experience with material characterization in a medical device context.
• Strong understanding of risk management in regulated environments.
• Familiarity with evidence-based decision making and quality systems.

Responsibilities

• Lead material-related quality activities and investigations.
• Collaborate with cross-functional teams to ensure robust evidence-based decisions.
• Apply ISO 14971 and other standards to drive risk-based decisions from material attributes to device safety.

Skills

Material characterization

Risk management

Regulated environment experience

Job description

Dexcom is seeking an experienced Design Quality Engineer specializing in material characterization and risk management to support advanced technology and lifecycle programs.

You will drive risk-based decision making using ISO 14971, ensuring traceability from material attributes to device safety and performance, while collaborating with multiple functions in a regulated environment to deliver robust evidence-based decisions.