Medtronic
Overview
Join to apply for the
Principal Quality Engineer
role at
Medtronic . We anticipate the application window for this opening will close on - 2 Oct 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
Principal Systems Quality Engineer
supporting the NPD surgical 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. Key Responsibilities
Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle. Conduct risk assessments and manage risk mitigation activities in accordance with ISO 14971 and other applicable standards. Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections. Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements. Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports. Design Validation And Verification Responsibilities
Define and manage systems requirements to ensure clarity, completeness, and testability. Collaborate with the system engineering team to define, refine, and manage system level requirements to ensure alignment with customer needs, clarity, completeness and testability. Oversee the requirements management process to ensure traceability and compliance. Responsible for verifying all design requirements are present and appropriately incorporated into risk management documentation. Develop and maintain critical to quality (CTQ) matrices to identify key product characteristics and ensure they meet customer needs and regulatory requirements ensuring traceability between them. Lead project teams in the testing of Clinician requirements of devices and products, including development of protocols, reports and execution of the Design Validations. Risk Management Responsibilities
Develop and manage risk management plans and reports, and conduct regular risk reviews. Collaborate with the system engineering team to define thorough hazard analysis to identify potential risks and mitigate them effectively. Conduct Failure Modes and Effects Analysis (FMEAs) to systematically evaluate potential failure modes and their impacts in collaboration with project teams. Analyze and review product complaints to predict and prevent future issues. Collaborate with the system engineering team to define detailed risk analysis to ensure all potential risks are identified and mitigated. Ensure product security measures are implemented and maintained to protect against potential vulnerabilities. Develop and manage post-market surveillance plans to monitor product performance and safety in the field. Maintain and curate risk logs to ensure accurate and up-to-date risk documentation. Minimum Requirements
Bachelor’s degree in Engineering, or a related technical field and 7 years relevant experience or a Master Degree and 5 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 systems engineering methodologies, quality assurance practices, risk management, 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. 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, interact with a computer, and communicate with peers and co-workers. 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 and offer a wide range of benefits, resources, and compensation plans designed to support you at every career and life stage. Salary ranges for U.S locations (excl. PR): $119,200.00 - $178,800.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, with variations based on experience, certification/education, market conditions, and location. Benefits information pertains to candidates hired within the United States. Additional benefits include health, dental and vision insurance, HSAs/FSAs, life insurance, disability leave, retirement plans, tuition assistance, and more, with certain variations by location. EEO statement: Medtronic is an equal employment opportunity employer. Reasonable accommodations are provided for qualified individuals with disabilities. See the company’s equal opportunity policy for full details. About Medtronic: Medtronic benefits and compensation plans. We lead global healthcare technology and boldly attack health problems by seeking solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ people. We are engineers at heart and engineer the extraordinary. Learn more about our business and commitment to diversity.
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Join to apply for the
Principal Quality Engineer
role at
Medtronic . We anticipate the application window for this opening will close on - 2 Oct 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
Principal Systems Quality Engineer
supporting the NPD surgical 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. Key Responsibilities
Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards. Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle. Conduct risk assessments and manage risk mitigation activities in accordance with ISO 14971 and other applicable standards. Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections. Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements. Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports. Design Validation And Verification Responsibilities
Define and manage systems requirements to ensure clarity, completeness, and testability. Collaborate with the system engineering team to define, refine, and manage system level requirements to ensure alignment with customer needs, clarity, completeness and testability. Oversee the requirements management process to ensure traceability and compliance. Responsible for verifying all design requirements are present and appropriately incorporated into risk management documentation. Develop and maintain critical to quality (CTQ) matrices to identify key product characteristics and ensure they meet customer needs and regulatory requirements ensuring traceability between them. Lead project teams in the testing of Clinician requirements of devices and products, including development of protocols, reports and execution of the Design Validations. Risk Management Responsibilities
Develop and manage risk management plans and reports, and conduct regular risk reviews. Collaborate with the system engineering team to define thorough hazard analysis to identify potential risks and mitigate them effectively. Conduct Failure Modes and Effects Analysis (FMEAs) to systematically evaluate potential failure modes and their impacts in collaboration with project teams. Analyze and review product complaints to predict and prevent future issues. Collaborate with the system engineering team to define detailed risk analysis to ensure all potential risks are identified and mitigated. Ensure product security measures are implemented and maintained to protect against potential vulnerabilities. Develop and manage post-market surveillance plans to monitor product performance and safety in the field. Maintain and curate risk logs to ensure accurate and up-to-date risk documentation. Minimum Requirements
Bachelor’s degree in Engineering, or a related technical field and 7 years relevant experience or a Master Degree and 5 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 systems engineering methodologies, quality assurance practices, risk management, 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. 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, interact with a computer, and communicate with peers and co-workers. 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 and offer a wide range of benefits, resources, and compensation plans designed to support you at every career and life stage. Salary ranges for U.S locations (excl. PR): $119,200.00 - $178,800.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, with variations based on experience, certification/education, market conditions, and location. Benefits information pertains to candidates hired within the United States. Additional benefits include health, dental and vision insurance, HSAs/FSAs, life insurance, disability leave, retirement plans, tuition assistance, and more, with certain variations by location. EEO statement: Medtronic is an equal employment opportunity employer. Reasonable accommodations are provided for qualified individuals with disabilities. See the company’s equal opportunity policy for full details. About Medtronic: Medtronic benefits and compensation plans. We lead global healthcare technology and boldly attack health problems by seeking solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ people. We are engineers at heart and engineer the extraordinary. Learn more about our business and commitment to diversity.
#J-18808-Ljbffr