We anticipate the application window for this opening will close on - 29 Sep 2025

 

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 Senior Hardware Quality Engineer to join our innovative team. The ideal candidate will have a strong background in hardware engineering, reliability testing, quality assurance, and regulatory compliance within the medical device industry. This role will be pivotal in ensuring the development and maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards and customer expectations.

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

• Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. 
• Define and manage sub-systems requirements to ensure clarity, completeness, and testability. Define requirements and assess risk through the use of DFMEA/DFMECA.
• Support engineering teams in the development of Critical to Function (CTF) matrixes for identification of critical functions and connecting these functions to specific design requirements.
• Responsible for planning, executing, and documenting design verification activities to ensure product designs meet specified requirements and regulatory standards.
• Support design, technical, and print reviews as part of the design verification process.
• Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports. 
• Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements. 
• Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections. 
• Evaluate product reliability through Reliability assessments and Test Systems Development.
• Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement hardware engineering processes that ensure product quality and compliance throughout the product lifecycle. 

Minimum Requirements

• Bachelor’s degree in Engineering, or a related technical field and 4 years relevant experience or a Master Degree and 2 years of relevant experience.

Nice to have

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

• Experience: Experience in Quality Assurance, Engineering  

• Industry Experience: Medical device industry. 

• Technical Skills: Proficient in hardware engineering methodologies, quality assurance practices, design verification, DFMECA, and regulatory compliance. 

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 to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Salary ranges for U.S (excl. PR) locations (USD):$96,800.00 - $145,200.00

This position is eligible for a short-term incentive called the Medtroni