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Medtronic Senior Quality Engineer in Minneapolis, Minnesota

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

In this exciting role as a Senior Quality Engineer, you will have responsibility for manufacturing validation, quality systems, and product quality for new product and process development at the Rice Creek Pharma Operations Manufacturing site.

Manufacturing Central Platform

Manufacturing Central Platform employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. The Manufacturing Central Platform offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. Rice Creek Pharma Operations, or Fridley, offers devices within the defibrillation solutions, surgical infection control, and diabetes management portfolios.

In this role, you will act as the quality engineer responsible for developing and validating the manufacturing process for new product development at Rice Creek Pharma Operations. The product portfolio includes new technologies and next-generation products in the combination, drug/device, product space.

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

  • Develop, characterize, and validate medical device manufacturing processes.

  • Provides guidance and knowledge on manufacturing process development and validation, focusing on quality systems and combination product compliance (FDA 21 CFR Parts 210, 211, and 820).

  • Collaborates with engineering and manufacturing functions to ensure the value stream complies with internal and/or external specifications, regulations, and standards such as ISO.

  • Provides knowledge in quality assurance, specifically, cGMP, pharmaceutical manufacturing, API handling and controls, clean room environments, environmental controls, and contamination.

  • Review equipment, inspection, process validations, changes, etc., to ensure compliance and assess the impact on product reliability, process capability, and compliance status.

  • Supports activities required for combination product compliance and ensures activities are completed in parallel with development activities on time and budget.

  • Employs First Time Quality mindset when developing manufacturing processes and ensuring adequate controls are instilled in the process.

  • Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.

  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

  • Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve, and control the mfg line and select processes.

  • Guides and contributes to failure analysis and issue resolution activities to ensure corrective/preventative action is accomplished.

  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

Required Knowledge and Experience

Requires a Baccalaureate degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice to Have

  • Medical device, pharma, or drug-device combination products preferred.

  • Experience with manufacturing execution systems.

  • Experience with equipment and software qualification.

  • Strong written and verbal communication skills in the English language.

  • Comprehensive understanding of applicable Work Instructions, SOPs, and ISO standards.

  • Working knowledge of statistical methods associated with Six Sigma and quality control.

  • Ability to maintain a professional and respectful relationship with coworkers and company.

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):$90,000.00 - $135,000.00

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

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