We anticipate the application window for this opening will close on - 4 May 2026

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Quality Engineering Manager to join our innovative team located at the North Haven, CT site. This role will be in the surgical operating unit managing the new product development quality team. The ideal candidate will have a strong leadership background in Quality New Product Development activities including reliability science, reliability planning and testing, risk management, product development, design controls and regulatory compliance within the medical device industry. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This position plays a critical role in the development of medical devices, ensuring patient safety is embedded throughout the product lifecycle.

         

         

Responsibilities may include the following and other duties may be assigned.

• Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
• May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
• 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.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.
• Participate in cross functional development teams, providing mechanical and/or electrical reliability engineering expertise. 
• Lead and mentor teams in the development, implementation, and maintenance of the reliability processes and standards
• Collaborate with cross-functional teams, to define and implement engineering and statistical processes that ensure product reliability and compliance throughout the product lifecycle.  
• Ensure compliance with relevant regulatory requirements, including FDA, ISO (e.g., 14971, 13485, 62304, FDA Part 820), and other international standards, and participate in regulatory audits and inspections.  
• Leading team in creating and maintaining the risk management file, including
• the risk management plans and reports, as well as conducting regular risk reviews. 

Must Have: Minimum Requirements

• Bachelor’s degree required
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.

 
Nice to Have

• Experience: Prior people leadership

• Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred. 

• Industry Experience: Medical device industry. 

• Technical Skills: Proficient in quality management systems, reliability, risk management, regulatory compliance, and statistics. 

• Other: Basic knowledge of human anatomy/physiology and surgical procedures.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required t