Senior Quality Engineer – Medical Devices & NPI Leader

MiniMed Group; California; Hybrid; USD 121,000 - 205,000; Full time

Benefits offered by this job

Competitive salary

Flexible benefits

Short Term Incentive (STI)

Job summary

MiniMed in Northridge, California is seeking a Principal Quality Engineer to lead on-site manufacturing quality operations, drive validation, and ensure regulatory compliance for next-generation medical devices.

You will collaborate with cross-functional teams, develop testing methods, lead NPI readiness, and apply risk management tools to prevent quality escapes while maintaining ISO 14971 alignment.

Qualifications

• Bachelor’s degree with 7+ years’ relevant experience or advanced degree with 5+ years of experience.
• Proficiency in statistical analysis tools such as Minitab with SPC/DOE experience.
• Proven CAPA ownership with end-to-end investigations and corrective actions.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocol for processing materials.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Designs inspection and testing mechanisms and conducts statistical analysis to assess products.

Skills

Statistical analysis

CAPA ownership

Risk mitigation

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree

Tools

Minitab

Job description

MiniMed in Northridge, California is seeking a Principal Quality Engineer to lead on-site manufacturing quality operations, drive validation, and ensure regulatory compliance for next-generation medical devices.

You will collaborate with cross-functional teams, develop testing methods, lead NPI readiness, and apply risk management tools to prevent quality escapes while maintaining ISO 14971 alignment.