Pre-Market Quality Program Manager

We anticipate the application window for this opening will close on - 21 Apr 2025

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

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.

The Pre-Market Quality Program Manager will join the Medtronic Energy and Component Center (MECC) team and will be responsible for managing various Quality projects. The Program Manager will work cross-functionally with the OU and GO&SC functions as necessary to plan and execute initiatives across the site such as First Time Quality (FTQ), Quality First Reviews, QMS Development Process Improvements, manage and report on KPIs, and more. The Program Manager requires cross-functional operations knowledge, business management skills, and the ability to provide direction and leadership to a variety of functions at the site. This role is on site 3-4 days a week at the Brooklyn Center, MN facility.

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

• Responsible for planning, initiating, monitoring, tracking and/or prioritizing engineering team's product development programs or projects and facilitating successful, on-time completion of actions.

• Execute tasks related to process improvements

• Strong understanding of the Development Process and can coach others through the PDP Cycle

• Use of critical thinking and problem-solving skills through the intricate details of development projects

• Set clear direction and management that aligns with defined practices and policies.

• Work closely with cross-functional teams to evaluate, develop and manage the design and construction of engineering projects to ensure delivery of a product or computer-based system through the design process, and into a finished state for internal customers.

• Establish meaningful metrics.

• Demonstrate strong problem-solving skills and the ability to ask critical questions

• Responsible for project performance, risk mitigation, issue resolution.

• Mentor team members to ensure each team member is fully engaged and contributing to project success

• Champion product development best practices such as collecting high-quality Voice of Customer inputs, early risk burn-down and design for manufacturability 

Must Have: Minimum Requirements

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

• Bachelor’s Degree with 5+ years of work experience in Quality and/or experience in a regulated industry OR Advanced Degree with 3+ years of work experience in Quality and/or experience in a regulated industry

Nice to Have: Preferred Qualifications

• Experience leading a complex projects/programs

• Experience with SPC, CAPA, NCMR, PDP processes

• Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously

• Ability to establish and maintain a trusted role with the various stakeholders in coordinating multiple functions across the organization

• PMP Certification

• Working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485:2016

• Manufacturing Experience

• Green Belt Six Sigma/DRM Training/Certification

• Effective verbal and written communication, analytical, influencing and interpersonal skills

• Demonstrated working knowledge of process validation, statistical methods, risk 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).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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 95,000+ 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.

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.