Principal Quality Engineer - Medtronic
Boulder, CO
About the Job
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
Careers that Change Lives
In this exciting role as a Principal Quality Systems Specialist you will have the responsibility to provide technical guidance and quality compliance for various respiratory and patient monitoring related products including breathing systems, airways devices and airway access, oximetry, capnography and patient warming devices. You will work in partnership with the R&D and OU Quality Teams, to maintain compliant quality systems and help develop improved strategies for quality. This will allow Medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements.
This role will be within the Acute Care and Monitoring (ACM) Operating Unit
The newly created ACUTE CARE AND MONITORING (ACM) OU, is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.
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 Principal Quality Engineer develops and maintains quality assurance programs to ensure that the performance and quality of Medtronic products conform to established standards and agency guidelines. Primary job responsibilities include CAPA management, audit program management and Quality Management System improvements.
Responsibilities may include the following and other duties may be assigned.
+ Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
+ Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
+ Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
+ Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
+ Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
+ Co-ordinates legal requests in support of government investigations or litigations.
+ Ensures the quality assurance programs and policies are maintained and modified regularly.
+ Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
+ Responsible for planning, organizing, writing, editing and releasing a variety of RFAIs associated with software, hardware, labelling, post-market vigilance and technical documentation. Coordinate interactions with worldwide competent authorities, notified bodies and international government authorities.
+ Drive Quality Management System (QMS) & product continuous improvement through CAPA management. Elevate issues to management as appropriate.
+ Coach new CAPA owners through processes and best practice.
+ Develop and maintain Compliance policies supporting the Risk Management program.
+ Provide expertise and guidance in interpreting governmental risk regulations, agency guidelines and internal policies to assure compliance.
+ Lead process improvement projects and assessment of quality plans.
+ Support Management during external/internal inspections and participate in the management of external/internal inspections.
+ Assist with external/internal audit preparation and responses to external / internal audit observations.
+ Maintain working knowledge of domestic and international medical device regulations and guidance documents and their impact on Medtronic’s operations.
Must Have: Minimum Requirements
+ Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Master’s Degree Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality.
+ Expertise in CAPA compliance & investigation techniques.
+ Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP.
+ Training in Risk Management, ISO 14971:2012, hazard analysis, issue impact analysis (IIA), and Design FMEA.
+ Must work well in cross-functional teams and be a self-starter.
+ Excellent written and verbal communication skills.
+ Excellent organizational skills.
+ Computer literacy must include proficiency with MS Office and experience with networks and applications.
Nice to Have
+ Master’s degree in Engineering, Program Management, or Compliance
+ _Lead Auditor Certification to ISO 13485:2016_
+ ASQ CQE, CQA, CSQE and/or CRE certification.
+ Familiar with statistical software tools (Minitab, Stat Graphics, Statistica),
+ Familiar with IEC 60601 and product specific industry standards.
+ Excellent interpersonal and influence skills including efficient collaboration, effective negotiation, and creative problem solving.
+ Strong technical experience in complex technology development programs including ability to understand technical information, discuss/decide on a wide array of engineering disciplines and technical/logistical issues.
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):$110,400.00 - $165,600.00
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.
At Medtronic, most positions are posted on our career site for 3-7 days.
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
A Day in the Life
Careers that Change Lives
In this exciting role as a Principal Quality Systems Specialist you will have the responsibility to provide technical guidance and quality compliance for various respiratory and patient monitoring related products including breathing systems, airways devices and airway access, oximetry, capnography and patient warming devices. You will work in partnership with the R&D and OU Quality Teams, to maintain compliant quality systems and help develop improved strategies for quality. This will allow Medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements.
This role will be within the Acute Care and Monitoring (ACM) Operating Unit
The newly created ACUTE CARE AND MONITORING (ACM) OU, is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.
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 Principal Quality Engineer develops and maintains quality assurance programs to ensure that the performance and quality of Medtronic products conform to established standards and agency guidelines. Primary job responsibilities include CAPA management, audit program management and Quality Management System improvements.
Responsibilities may include the following and other duties may be assigned.
+ Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
+ Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
+ Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
+ Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
+ Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
+ Co-ordinates legal requests in support of government investigations or litigations.
+ Ensures the quality assurance programs and policies are maintained and modified regularly.
+ Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
+ Responsible for planning, organizing, writing, editing and releasing a variety of RFAIs associated with software, hardware, labelling, post-market vigilance and technical documentation. Coordinate interactions with worldwide competent authorities, notified bodies and international government authorities.
+ Drive Quality Management System (QMS) & product continuous improvement through CAPA management. Elevate issues to management as appropriate.
+ Coach new CAPA owners through processes and best practice.
+ Develop and maintain Compliance policies supporting the Risk Management program.
+ Provide expertise and guidance in interpreting governmental risk regulations, agency guidelines and internal policies to assure compliance.
+ Lead process improvement projects and assessment of quality plans.
+ Support Management during external/internal inspections and participate in the management of external/internal inspections.
+ Assist with external/internal audit preparation and responses to external / internal audit observations.
+ Maintain working knowledge of domestic and international medical device regulations and guidance documents and their impact on Medtronic’s operations.
Must Have: Minimum Requirements
+ Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Master’s Degree Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality.
+ Expertise in CAPA compliance & investigation techniques.
+ Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP.
+ Training in Risk Management, ISO 14971:2012, hazard analysis, issue impact analysis (IIA), and Design FMEA.
+ Must work well in cross-functional teams and be a self-starter.
+ Excellent written and verbal communication skills.
+ Excellent organizational skills.
+ Computer literacy must include proficiency with MS Office and experience with networks and applications.
Nice to Have
+ Master’s degree in Engineering, Program Management, or Compliance
+ _Lead Auditor Certification to ISO 13485:2016_
+ ASQ CQE, CQA, CSQE and/or CRE certification.
+ Familiar with statistical software tools (Minitab, Stat Graphics, Statistica),
+ Familiar with IEC 60601 and product specific industry standards.
+ Excellent interpersonal and influence skills including efficient collaboration, effective negotiation, and creative problem solving.
+ Strong technical experience in complex technology development programs including ability to understand technical information, discuss/decide on a wide array of engineering disciplines and technical/logistical issues.
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):$110,400.00 - $165,600.00
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.
At Medtronic, most positions are posted on our career site for 3-7 days.
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
Source : Medtronic