Pre-Market Quality Program Manager

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.