Quality Engineering Director, Surgical Post-Market

Medtronic • Boston, MA

422d • $187,200 - $280,800

About The Position

The Quality Engineering Director for Surgical Post-Market Risk at Medtronic is responsible for leading the design and development of new medical device products and software systems. This role involves overseeing quality assurance and control systems, guiding the conceptualization of new methodologies, and managing the development of new concepts from design to market release. The director will also coordinate activities with suppliers and consultants, ensuring timely delivery and efficient operation of the function.

Requirements

• Baccalaureate degree or equivalent with a minimum of 10 years of combined experience in quality, engineering or a related function with 7+ years of managerial experience, or an advanced degree with a minimum of 8 years of combined experience in quality, engineering or a related function with 7+ years of managerial experience.
• Risk management experience in the medical device industry.
• Risk Management File lifecycle accountability.
• Experience in engaging with Regulatory Agencies and customers/clinicians.
• Statistical analysis tools and techniques.
• Significant breadth and depth in quality decision making, risk management, quality engineering, reliability engineering, and writing for compliance.

Nice To Haves

• DRM Certification
• Experience with complex capital, medical devices or software
• Exceptional engineering knowledge and leadership capability within a business unit
• Reliability Engineering Test experience
• Deep domain expertise and extensive engineering and industry expertise.

Responsibilities

• Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
• Develops, evaluates, implements and maintains technical quality assurance and control systems or reliability systems and standards.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Benefits

• Competitive Salary
• Flexible Benefits Package
• Short-term incentive called the Medtronic Incentive Plan (MIP)
• Annual long-term incentive plan

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees