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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

Medtronic Diabetes helps people gain better control and awareness over their diabetes. We work in the challenging space where medical devices are in the hands of everyday people, and those people expect state-of-the-art technology to help make managing their diabetes easier and more connected.

In this exciting role as an Engineering Manager, you will have responsibility for managing a team of hardware and process engineers involved in the development and commercialization of the new products for the Diabetes Group. In addition, you will act as a Quality Core Team Member you will have responsibility for being the focal point of Quality for Medtronic product and system development programs in the Diabetes business. You will be a core team member leading and representing the Quality function to reach the highest level of quality and clinical outcomes for these products. In this role, you will represent the voice of quality by providing technical expertise to the Product Development activities and driving efficiency to the processes through various process improvements. This role will plan all quality deliverables, activities, resources, application of a rigorous approach in design, manufacturability, and reliability, and be the voice of quality throughout the development lifecycle.

Diabetes

The Diabetes Group is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes, so people with diabetes can enjoy greater freedom and better health.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.

A Day in The Life

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

• Provide direct supervision, coaching and mentoring to the design and process development quality engineers in your team. This includes work direction, priority and objective setting, development opportunities, training, and performance management.

• Plans, directs and implements quality related aspects of the company's design and development of new products within the portfolio. Ensures compliance in development processes.

• May develop, evaluate, implement and maintain technical quality assurance and control systems and standards pertaining to materials, techniques, or company products including ensuring a thorough connection between design controls deliverables (from design planning, requirements development, risk management, design verification/ validation through design transfer) in the DHF to process validation, production and process controls and content captured in the DHR.

• Serves as a primary focal point and contact for all quality aspects of a project. Represents and make decisions on behalf of quality on the core team.

• Maintains alignment and manages execution across all Global Quality disciplines.

• Collaborate with R&D, system engineering, our product management organization and partner engineering teams in making product design decisions.

• Drive establishment of Quality, Reliability, and product development strategies to improve safety, reliability, and usability of the product family for our patients.

• Provide leadership and guidance to create consistency in our architecture, interface, and designs that will enable platforms and future product expansion.

• Drive development of test strategies for complex systems, partnering with regulatory on strategies for emerging technology.

• Oversees the investigation and evaluation of existing technologies.

• Guides the conceptualization of new methodologies, materials, machines, processes or products. Ensures risk management processes are fully integrated into development processes and support production and process controls.

• Directs the development of new concepts from initial design to market release. Drives alignment between pre and post market quality teams, ensuring seamless transfers to production.

• Manages feasibility studies of the design to determine if capable of functioning as intended.

• Monitors documentation maintenance throughout all phases of research and development.

• Regularly interacts with site leadership. Represents quality as a member of the development staff as well as serving on the quality staff.

• Selects, develops and evaluates personnel to ensure the efficient operation of the function.

• Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different operating unit (OU) strategies and products.

• Lead external and internal regulatory audits and inspections as it pertains to design and development and sustaining.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Bachelors Degree in Engineering or Science field with 5+ years of experience in quality and/or engineering with 3+ years of managerial experience

OR

Masters Degree in Engineering or Science field with 3+ years of experience in quality and/or engineering with 3+ years of managerial experience.

Nice to Have

• Experience working in a regulated industry (e.g., FDA-regulated)

• Master’s Degree in Engineering, Quality, Regulatory, or related.

• Working knowledge of electromechanical medical devices with embedded firmware and systems with mobile and cloud applications

• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, IEC 62304, IEC 60601-1, MDD & EU MDR.

• Experience in Design-Reliability-Manufacturing (DRM) or equivalent corporate design and/or manufacturing process improvement initiative

• Experience with leading large, complex initiatives of strategic importance to the business unit, involving large cross-functional teams.

• Project experience in hardware testing practices, methodologies, and techniques, particularly in testing medical devices is a plus.

• Ability to author technical reports, business correspondence and standard operating procedures.

• Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.

• FDA regulatory experience- e.g., presenting during FDA audits, responding to regulatory inquiries, communicating directly with FDA statisticians.

• Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.

• Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.

• Self-Starter with a sharp focus on quality and customer experience

• Certifications in Quality Engineering, Quality Management or Program Management.

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):$136,000.00 - $204,000.00

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.

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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) .

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