Prin Hardware Design Assurance Engineer, Pre-Market Quality

$116,000 - $174,000/Yr

Medtronic - San Diego, CA

Full-time - Mid Level

San Diego, CA

10,001+ employees

Miscellaneous Manufacturing

About the position

The Principal Hardware Design Assurance Engineer in the Pre-Market Quality organization at Medtronic will serve as a subject matter expert, providing quality engineering support for the design and development of new diabetes products. This role focuses on ensuring that all hardware design work products meet design control requirements and involves collaboration across various functions to drive successful product development and compliance with regulatory standards.

Responsibilities

• Lead and provide quality engineering support for new product development programs.
• Ensure compliance with design control requirements for hardware design work products.
• Develop deliverables for risk management, including dFMEA and pFMEA.
• Utilize statistical techniques for data analysis to inform design decisions.
• Collaborate with cross-functional teams to ensure successful execution of business goals.
• Facilitate project teams in navigating enterprise and business unit processes.
• Review product design documentation for quality characteristics and manufacturability.
• Participate in design change control evaluations and technical reviews.
• Support design transfer planning and ensure projects transition to manufacturing facilities.
• Mentor junior quality engineers and provide training on compliance with quality requirements.

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 insulin delivery systems.
• Knowledge of FDA Quality System Regulation, ISO 13485, and Medical Device Directive.
• Proficiency in statistical methods and tools for data analysis.

Nice-to-haves

• 5+ years experience with medical devices involving insulin delivery.
• Working knowledge of FDA Quality System Regulation and ISO 13485.
• Proficiency in Spanish.

Benefits

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