Job
Description
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 As a Principal Project Management Specialist, you will be a key member of the Medtronic Quality Engineering team responsible for maintaining the highest standards of product reliability and patient well-being across the Cranial and Spinal Technologies (CST) Operating Unit. CST provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. Responsibilities may include the following and other duties may be assigned Responsible for planning, initiating, monitoring, tracking and/or prioritizing MEIC Quality engineering team's programs and facilitating successful, on-time and within budget execution. Sets clear direction and operating mechanisms for ensuring effective monitoring and reporting of performance and safety of commercialized products, ensuring ongoing compliance with regulatory standards. Support day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues, identifying project risks and accountability for deliverables across multiple entities. Establishes and monitors meaningful metrics for success. Responsible for project performance, risk management, administration, financial management, budgeting, capital planning, forecasting and issue resolution. Manage communication strategies with MEIC and applicable CST entity stakeholder(s) for appropriate mapping of training needs, knowledge transfers and prioritization of work for sustainable long term growth. Support continuous improvement efforts and drive associated change implementation strategies for the product or process being supported. Required Knowledge And Experience Familiarity with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant standards for ensuring compliance to regulatory requirements. Ability to collaborate across the matrix – update crossfunctional (and leadership) teams on project status or issues to the organization and providing training on relevant procedures and policies. Participating in audits (where applicable) and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Previous experience working in a cross-functional team environment. Develop templates and lead trainings based on quality system regulations, applicable standards and guidance. Working knowledge and experience with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Good verbal and written communication skills Ability to influence others across the organization and/ or locations Hands-on experience with Quality Management Systems (Post market surveillance and reporting, complaint analysis, product acceptance and Design/ Change Control) Strong written, verbal and project management skills 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. 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. 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 Show more Show less
