Quality Engineering Program 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 LifeQuality Program Manager (QCTM) role in the SH&A OU for the Accessory Franchise programWithin our Structural Heart Design Assurance Group in Medtronic, plc, we focus on providing Quality support across all aspects of PDP from premarket product development to post market product surveillance.We participate in the designprocess to ensure the performance and safety of the Structural Heart devices we develop, is assured and maintained throughout the product lifecycle.This position requires the successful candidate to be on site 4 days per week.Come for a job, stay for a careerA Day in The Life Of:Represent, lead, and is accountable for the functional group on the Core Team and is an integral participant in the planning and execution of the project(s)Can process requirements from multiple quality sub-function stakeholders and represent in decision making processProject-manage functional tasks and deliverables per the project plan.Proactively identify and manage project dependencies and risks.Helps establish program objectives, timelines, milestones, and budgetsProvide input to functional manager on extended team member performance and developmentApply knowledge of design control principles and quality engineering techniques throughout the product development processIdentify and manage risk using a FMECA and/or other risk management toolsAbility to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harmsEstablish verification and validation strategies with R&D and Regulatory to assure an efficient approval pathDevelop master test plans that encompass design verification, design validation and process validation activities that are sufficient to meet regulatory requirements and quality objectivesProvide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and testedApply understanding of anatomy & physiology with engineering knowledge in materials and processes to come up with designInterface effectively and build relationships with team members, other staff and key technology and component suppliers, both locally and globallyKey Skills & ExperienceRequires a Level 8 degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experiencePreferred QualificationsExperience leading quality organization (QCTM) on new product development teams through commercialization, primarily catheter developmentThorough understanding and experience in design controls, V&V, and Risk Management - both commercial and development.System-thinking and process mapping, ability to effectively identify interfaces, dependencies, and control pointsDemonstrated ability in stakeholder management and coordinating complex assignments with cross-functional teamsUnderstanding of 21CFR820, ISO*****, and ISO*****Experience owning or managing a QMS procedure/processAdditional product Reliability responsibilities may include lean design tools (DRM), change management, and risk response.Medtronic offer a competitive salary and flexible Benefits PackageIJA #INDSPhysical Job RequirementsThe 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.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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.This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).About MedtronicWe 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.