Prin Hardware Design Assurance Engineer, Pre-Market Quality

$116,000 - $174,000/Yr

Medtronic - Los Angeles, CA

Full-time - Mid Level

Los Angeles, CA

10,001+ employees

Miscellaneous Manufacturing

About the position

The Principal Hardware Design Assurance Engineer in Pre-Market Quality at Medtronic plays a crucial role in supporting the development of innovative diabetes products. This position involves leading quality engineering efforts throughout the product design and development phases, ensuring compliance with quality system elements and regulatory standards. The engineer will act as a subject matter expert, collaborating with cross-functional teams to drive successful product outcomes and improve the lives of individuals with diabetes.

Responsibilities

• Lead and provide quality engineering support for new product development programs related to diabetes products.
• Ensure compliance with design control requirements, including documentation and deliverables for risk management.
• Review product design documentation for quality characteristics such as manufacturability and reliability.
• Facilitate design and process risk management deliverables, including dFMEA and pFMEA.
• Utilize statistical techniques for data analysis to inform design decisions and validate test methods.
• Collaborate with various teams to ensure design outputs are traced to manufacturing process specifications.
• Participate in design transfer planning and ensure projects transition smoothly to manufacturing facilities.
• Mentor junior quality engineers and provide training on compliance with quality requirements.
• Support regulatory submissions and participate in audits and inspections.

Requirements

• Bachelor's degree in engineering or related sciences with 7+ years of relevant quality engineering experience, or a Master's degree with 5+ years of experience.
• Experience with medical devices, particularly in insulin delivery systems.
• Knowledge of FDA Quality System Regulation, ISO 13485, and Medical Device Directive.

Nice-to-haves

• 5+ years of experience with medical devices involving insulin delivery.
• Proficiency in Spanish.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive plan (Medtronic Incentive Plan).
• Comprehensive health insurance and retirement plans.