Senior Quality Engineering Manager

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

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.

Medtronic seeks candidates who will meet our customer expectations by striving without reserve for the highest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action.

As the Senior Quality Engineering Manager , you will use your knowledge of process controls and quality engineering techniques to continually improve the quality of products and ensure that they are developed, manufactured and tested in accordance with regulatory and customer requirements.

You will oversee the Quality staff supporting component process development for Medtronic’s Danvers, MA campus and partner closely with Product Development and R&D teams. You will also provide leadership and vision with a focus on prevention, continuous improvement, and customer satisfaction.

Join a Culture of Collaboration and Innovation!

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

Provide leadership and supervision of Quality Engineers, , including hiring, training, evaluating, developing, and directing staff.

Apply knowledge of process control tools, investigational, and analytical techniques (i.e. SPC, DOE, cause and effect, reliability, etc.) to support data driven decisions.

Provide leadership to the quality team to proactively identify quality signals and trends and drives actions needed to mitigate or reverse adverse quality trends.

Serve as the subject matter expert and process owner for the manufacturing area’s application of the Quality System during audits, internal and external (e.g., by FDA, Notified Body, Corporate).

May develop, evaluate, implement, and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.

Monitors documentation maintenance throughout all phases of research, development, and design transfer.

Collaborate cross-functionally to identify solutions to complex problems associated with systems, processes, and design. Partnership with both local operations teams, downstream manuf. sites, and Operating Units responsible for product design and reliability are critical to success in this role.

Support and lead investigation of complex product problems. Identifies and manages corrective actions resulting from problem investigations.

Coach and develop staff of varying levels by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receive appropriate knowledge, skill development and growth opportunities. Manage performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.

Regularly interact with site and Operating Unit leadership.

Establish operating policies and procedures. Interprets, executes, and recommends modifications to policies and procedures.

Establish and successfully execute quality initiatives and plans which align to business objectives and initiatives.

Must Have: Minimum Requirements

Bachelors Degree in engineering, science or technical field with 7 years of experience in Quality and/or Engineering with 5 years of managerial/leadership experience OR Advanced Degree in engineering, science or technical field with 5 years of experience in Quality and/or Engineering with 3 years of managerial/leadership experience.

Nice to Have

Advanced degree in Engineering

Experience in a regulated industry

Experience in Production and Process controls including Process Validation (IQ, OQ, PQ), process controls, risk analysis, and Non-conformance management.

Experience in statistical process controls (SPC).

Experience with Medical Device manufacturing

Experience with external and internal audits

Certification/Knowledge and experience in areas of Lean Manufacturing and Six Sigma

Experience driving continuous improvement using such tools as Lean, Six Sigma, Kaizen, and First-Time Quality.

ASQ certification in Quality Engineering

Design for Reliability and Manufacturing certification

Experience in related engineering areas, e.g. R&D, Supplier Controls or Manufacturing is beneficial.

Experience and working knowledge of FDA regulations/ISO standards for medical devices

Experience with inspection automation

Strong interpersonal, organizational, influence and project management skills

Demonstrated skills in decision making

Demonstrated ability in coaching/developing team members

Demonstrated communication skills, both verbal and written

Detail oriented utilizing rigor and strong analytical techniques to identify and solve problems

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):$160,000.00 – $240,000.00

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?pagename=signon&conum=30601&coaffid=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. Youre 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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