Senior Hardware Design Quality Engineer – Medical Devices

Minimed; Los Angeles (CA); Hybrid; USD 94,400 - 141,600; Full time

Benefits offered by this job

Competitive salary

Health, dental, and vision insurance

401(k) plan with company match

Paid time off and holidays

Job summary

A health technology company is seeking a Senior Hardware Design Quality Engineer to oversee Design Quality Engineering for diabetes management products. The role involves ensuring compliance with FDA regulations and ISO standards, leading risk management processes, and collaborating across teams. Candidates should have a relevant degree and substantial experience within a medical device environment. The position offers competitive compensation and flexible benefits, and requires on-site work in Northridge, CA at least 3 days a week.

Qualifications

• Minimum of 4 years of experience in a Design Quality role within a regulated medical device environment.
• At least 2 years of experience leading risk management activities across product lifecycle.
• Strong knowledge of FDA QSR and ISO standards.

Responsibilities

• Lead Design Assurance and Control activities for diabetes products.
• Ensure compliance with FDA QSR, ISO 13485, and global regulatory requirements.
• Review and approve system-level design outputs for safety and usability.

Skills

Design Quality Engineering

Risk management

Regulatory compliance

Statistical analysis

Cross-functional communication

Education

Bachelor’s degree in Engineering, Science or related discipline

Tools

Minitab

Job description

A health technology company is seeking a Senior Hardware Design Quality Engineer to oversee Design Quality Engineering for diabetes management products. The role involves ensuring compliance with FDA regulations and ISO standards, leading risk management processes, and collaborating across teams. Candidates should have a relevant degree and substantial experience within a medical device environment. The position offers competitive compensation and flexible benefits, and requires on-site work in Northridge, CA at least 3 days a week.