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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

Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards.

Job Title: Quality Engineer II

Location: Boston, MA or North Haven, CT

Company: Medtronic (legacy Covidien)

Job Description:

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Quality Engineer II to join our innovative team. The ideal candidate will have a strong background in New Product Development (NPD) Systems Engineering, 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 int 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, as well as 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.

Qualifications:

Minimum Requirements:

• Education: Bachelor’s degree in Engineering, or a related technical field.

• Experience: Nice to Have: 5+ years of applicable experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline).

• Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.

• Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.

• Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.

• Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.

Preferred Qualifications:

• Certifications: Advanced degree, 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.

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 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 Day in the Life 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.

EEO

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.

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: http://www.uscis.gov/e-verify/employees .

How to Apply:

Interested candidates should submit their resume and cover letter through the Medtronic careers portal at [insert application link].

Join us in our mission to alleviate pain, restore health, and extend life. Apply today!

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):$76,000.00 - $114,000.00

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