Medtronic
Principal Software Quality Engineer
Medtronic, Mounds View, Minnesota, United States,
We anticipate the application window for this opening will close on - 26 Nov 2024
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
Principal Software Quality Engineer
Careers that Change Lives
Transforming Patient Management with Smart Technology!
At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work.
Medtronic Coronary & Renal Denervation (OHS) Operating Unit develops the next generation medical technologies that alleviate pain, restore health, and extend life for millions of patients across the world.
Treatments We Offer:
Renal Denervation
Key Technologies
Symplicity Spyral™ Renal Denervation (RDN) System
In our Coronary and Renal Denervation Design Assurance Team, our purpose is to increase product development process rigor to ensure robust understanding of designs, documentation of compliance to requirements and timely, high-quality product launches that satisfy patient needs and reduce customer complaint rates.
This position is in Mounds View, MN within the Coronary & Renal Denervation (OHS) Operating Unit and requires on-site presence four days a week.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
A Day in the Life:
The Manager is accountable for the overall health of their scrum teams. This includes responsibility for building and maintaining a team with the right level of skills and experiences to meet the team’s business objectives. The Manager is ultimately accountable for their teams’ performance and execution.
In general, the following responsibilities apply for the Principal Software Quality Engineer role. This includes, but is not limited to the following:
Responsible for various software quality assurance functions during the PDP development lifecycle of a complex electro-mechanical medical devices – in partnership with Software Developers and Testers.
As the quality assurance software SME, you will ensure product compliance into the design and development of software solutions, including embedded, and Cloud-based systems, with a focus on patient safety and regulatory adherence.
Support CRDN and European-based Software teams
Responsible for identifying and tracking software quality metrics
Responsible for supporting software test strategy/planning, software development documentation, software requirements, test protocol development, testing, verification/validation plan/reports, software release and software design history files within the software development lifecycle (Agile, Waterfall, SAFe, DevOps), ensuring alignment with regulatory standards.
Provide input towards user needs, software requirements and Software reliability/ performance.
Leverage a strong understanding of C++, Python in quality assurance activities to support software compliance, security, and overall product quality in a regulated environment.
Participate in system risk analysis and software FMEA to identify and mitigate risks, focusing on patient safety and adherence to regulatory compliance.
Responsible for maintaining software traceability matrices to ensure all software related design requirements, outputs, verification, and validation activities are fully documented, transparent, and compliant with regulatory requirements.
Participate in any software complaint investigations
Collaborate with R&D Engineering teams to review and implement best practices in software security, safeguarding patient data and product integrity.
Lead quality improvement projects to continuously enhance software quality operating methods, processes, and procedures (ISO13485, IEC62304, IEC82304, HIPAA, FDA, Security Standards, Data Privacy)
As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
Member of Software Change Control Board to manage changes post design freeze
Own validation of software associated with system and sub-system tests
Work independently to plan and schedule own activities necessary to meet timelines.
Qualifications -
MUST HAVE - MINIMUM REQUIREMENTS:
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
Bachelor’s degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or related technical field.
Minimum of 7 years of technical experience, or advanced degree with 5 years of technical experience.
Nice to Have
Working knowledge of ISO13485, IEC62304, IEC62304, AAMI TIR45, HIPAA
Experience in software design, development, verification, validation, and testing activities, particularly with embedded software.
Experience in SDLC environments using ALM tools (PTC Codebeamer, Atlassian Suite), defect tracking tools (Jira), and CI/CD tools (Gitlab, Jenkins).
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
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. (ADA-United States of America)
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):$116,800.00 - $175,200.00
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, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Welcome to our new Careers Site!
If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will…
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email AskHR@medtronic.com
To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com
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
Principal Software Quality Engineer
Careers that Change Lives
Transforming Patient Management with Smart Technology!
At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work.
Medtronic Coronary & Renal Denervation (OHS) Operating Unit develops the next generation medical technologies that alleviate pain, restore health, and extend life for millions of patients across the world.
Treatments We Offer:
Renal Denervation
Key Technologies
Symplicity Spyral™ Renal Denervation (RDN) System
In our Coronary and Renal Denervation Design Assurance Team, our purpose is to increase product development process rigor to ensure robust understanding of designs, documentation of compliance to requirements and timely, high-quality product launches that satisfy patient needs and reduce customer complaint rates.
This position is in Mounds View, MN within the Coronary & Renal Denervation (OHS) Operating Unit and requires on-site presence four days a week.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
A Day in the Life:
The Manager is accountable for the overall health of their scrum teams. This includes responsibility for building and maintaining a team with the right level of skills and experiences to meet the team’s business objectives. The Manager is ultimately accountable for their teams’ performance and execution.
In general, the following responsibilities apply for the Principal Software Quality Engineer role. This includes, but is not limited to the following:
Responsible for various software quality assurance functions during the PDP development lifecycle of a complex electro-mechanical medical devices – in partnership with Software Developers and Testers.
As the quality assurance software SME, you will ensure product compliance into the design and development of software solutions, including embedded, and Cloud-based systems, with a focus on patient safety and regulatory adherence.
Support CRDN and European-based Software teams
Responsible for identifying and tracking software quality metrics
Responsible for supporting software test strategy/planning, software development documentation, software requirements, test protocol development, testing, verification/validation plan/reports, software release and software design history files within the software development lifecycle (Agile, Waterfall, SAFe, DevOps), ensuring alignment with regulatory standards.
Provide input towards user needs, software requirements and Software reliability/ performance.
Leverage a strong understanding of C++, Python in quality assurance activities to support software compliance, security, and overall product quality in a regulated environment.
Participate in system risk analysis and software FMEA to identify and mitigate risks, focusing on patient safety and adherence to regulatory compliance.
Responsible for maintaining software traceability matrices to ensure all software related design requirements, outputs, verification, and validation activities are fully documented, transparent, and compliant with regulatory requirements.
Participate in any software complaint investigations
Collaborate with R&D Engineering teams to review and implement best practices in software security, safeguarding patient data and product integrity.
Lead quality improvement projects to continuously enhance software quality operating methods, processes, and procedures (ISO13485, IEC62304, IEC82304, HIPAA, FDA, Security Standards, Data Privacy)
As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
Member of Software Change Control Board to manage changes post design freeze
Own validation of software associated with system and sub-system tests
Work independently to plan and schedule own activities necessary to meet timelines.
Qualifications -
MUST HAVE - MINIMUM REQUIREMENTS:
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
Bachelor’s degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or related technical field.
Minimum of 7 years of technical experience, or advanced degree with 5 years of technical experience.
Nice to Have
Working knowledge of ISO13485, IEC62304, IEC62304, AAMI TIR45, HIPAA
Experience in software design, development, verification, validation, and testing activities, particularly with embedded software.
Experience in SDLC environments using ALM tools (PTC Codebeamer, Atlassian Suite), defect tracking tools (Jira), and CI/CD tools (Gitlab, Jenkins).
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
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. (ADA-United States of America)
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):$116,800.00 - $175,200.00
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, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) .
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Welcome to our new Careers Site!
If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will…
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email AskHR@medtronic.com
To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com