Prin Hardware Design Assurance Engineer, Pre-Market Quality

$116,000 - $174,000/Yr

MIN Medtronic Minimed Inc. - San Diego, CA

Full-time - Senior

San Diego, CA

About the position

The Principal Hardware Design Assurance Engineer, Pre-Market Quality at Medtronic plays a crucial role in supporting the development of diabetes products. This position involves leading quality engineering efforts throughout the product design and development phases, ensuring compliance with quality standards and regulations. The engineer will act as a subject matter expert, guiding teams in risk management, design control, and manufacturing process development to deliver safe and effective medical devices.

Responsibilities

• Lead and provide quality engineering support for new product development programs.
• Ensure compliance with design control requirements and documentation throughout the product design phases.
• Develop deliverables for risk management, including dFMEA and pFMEA.
• Review product design documentation for quality characteristics such as manufacturability and reliability.
• Collaborate with cross-functional teams to ensure essential design outputs are traced to manufacturing specifications.
• Participate in design verification and validation activities, ensuring compliance with FDA regulations and internal standards.
• Mentor junior quality engineers and provide training on quality compliance and regulations.
• Assist in writing technical submissions for regulatory purposes.

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 through the Medtronic Incentive Plan (MIP).
• Comprehensive health insurance options.
• 401(k) retirement plan with company matching contributions.