This position has the responsibility and authority to be an integral team member for the development of new Medical devices, specifically surgical robots. Individual will be responsible for leading the product quality and reliability assessment. Individual must be well rounded with a strong statistical background and recent hands on experience with quality and reliability tools and their application. Position will include early development projects thru transition to manufacturing. Individual must be able to multitask and work within a schedule. Medtronic is currently seeking a Sr Hardware Design Assurance Quality Engineer. Do meaningful work, make a difference, and improve lives ?? starting with your own. The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. A Day in the Life ? Integral member of design team required to lead activities related to the quality and reliability of the design. ? Design trade-off studies. ? Risk assessment. ? Responsible for Supplier integration. ? Work closely with Development Engineering to assure appropriate Requirement definitions are established. ? Work with development engineering and manufacturing engineering to translate design requirements to manufacturing requirements. ? Development of clinically relevant test methods for development and manufacturing testing. ? Actively participate in the product development cycle to ensure quality issues are addressed and resolved prior to release. Complete reviews and audits of Design History File documentation. ? Establish appropriate qualifications, validations, inspection plans and gauging for both new products and changes to released product. Assure the resolution of all issues raised by testing. ? Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Establish incoming inspection requirements and revise as necessary. ? Lead problem solving efforts to identify and resolve difficult quality issues to ensure production of safe and effective medical devices. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. ? Perform machine and process capability and performance studies. Lead the implementation of changes and upgrades to systems, procedures, and processes to improve product quality. Provide well-written reports and supporting documentation. ? Implement corrective and preventive actions to improve quality. Ensure documentation and findings are completed on time and in a timely manner in accordance with FDA and European Regulatory agency standards and procedures. ? Promote continuous improvement through the use of such tools as Lean, Six Sigma and Kaizen. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Collaborates with mechanical engineering and manufacturing functions to ensure supplier is capable of producing and inspecting components Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume Education: ? B.S./B.A. in Engineering or similar related field Years of Experience: ? 4+ years of previous experience in a Reliability or Quality position in a regulated environment with B.S./B.A. ? 2+ years of previous experience in a quality position in a regulated environment with M.S./M.A. Nice to Have ?? (Preferred Qualifications): Mechanical Design Experience Understanding of metal and injection molding manufacturing processes Strong understanding of FDA standards. Medical device experience. CQE Demonstrated use of Statistical Analysis tools. Experienced in Planning, executing and reporting Design Verification. ISO standards knowledge About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let ??s work together to address universal healthcare needs and improve patients ?? lives. Help us shape the future. Physical Job Requirements 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. (ADA-United States of America) We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us. Engineering The opportunity to invent. The benefit of joining a leader. The power to improve lives. You ??ll find all that and more here. Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world. Our mission ??to alleviate pain, restore health, and extend life ? is more than a statement. It ??s a belief that our employees live every day. Join us, and bring the power of your unique point of view to our culture of collaboration and innovation. ??The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it. ? ??Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on. ? ??Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers. ? 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. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.