Pre Market Supplier Quality Engineer Ii

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 LifeMedtronicAt Medtronic, we value what makes you unique.Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations.Our PurposeAt our Pre-Market Supplier Quality Engineering Dept in Medtronic, plc.you will join a diverse global team of engineers who work on new product development (NPD) projects supporting cross functional teams in the Structural Heart and Aortic Operating unit.This role will be an opportunity to work on new component designs and processes at our supplier partners and bring them from concept to commercial phases.This role requires someone with strong technical skills as well as someone with a patient centric mindset to ensure all Design and QMS requirements are delivered on time and in compliance with our standards.Come for a job, stay for a careerA Day in The Life Of:Provides Pre-Market Quality Engineering support to New Product Development (NPD), working in partnership with R&D, Suppliers and Post-Market Supplier Quality Teams, to qualify and deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.Monitor parts from acquisition through the development and pre-market manufacturing cycles and communicates and resolves supplier-related problems as they occur.For new suppliers, support audits to ensure good manufacturing practices (GMP) and quality standards are met.Evaluates suppliers internal functions to assess their overall performance and provide feedback in assessment of their operation.Provide technical guidance and quality compliance throughout the NPD lifecycle on newly qualified parts and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.Collaborate with cross functional engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.May take part in global supplier visits to review processes and capabilities.Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented.Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes).Key Skills & ExperienceMinimum Level 8 degree in Science, Engineering, or relevant discipline.2+ years Engineering and/or Quality experience in the medical device industry or related field.You are a dynamic team player and can work effectively and proactively on cross functional teams.Excellent problem-solving skills are desirable.You are a good communicator and fluent in English, both verbal and written.Strong Technical skills.Previous Experience in PPAP and/or validation of parts and processes is an advantage.Medtronic offer a competitive salary and flexible Benefits Package#IJPhysical 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.