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Sr Reliability Engineer (Santa Rosa, CA, Galway Ireland or Remote with US)

Company: Medtronic
Location: Santa Rosa
Posted on: May 3, 2021

Job Description:

Sr Reliability Engineer (Santa Rosa, CA, Galway Ireland or Remote with US) Location: Santa Rosa, California, United States Requisition #: 210008NL Post Date: Apr 05, 2021Sr. Reliability EngineerReq Number 210008NLSanta Rosa, CA,Galway, Ireland orRemote within the USCareers that Change LivesIn this exciting role as a Senior Reliability Engineer, you will have responsibility for ensuring the quality, reliability, and safety of medical devices during product development, design transfer, and post market release. You will work with our current products and lead the quality assurance programs, policies, processes, procedures and controls in compliance with the evolving and complex US and global requirements of the medical device industry, with particular focus on the updated requirements of the Medical Device Regulation in Europe (EU MDR).Coronary Renal DenervationCoronary Renal Denervation (CRDN) therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.A Day in the LifeResponsibilities may include the following and other duties may be assigned. + Develops, coordinates and updates the list of industry standards applicable to CRDN products and the level of compliance claimed to each standard. + Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. + Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. + Completes risk analysis studies of new design and processes. + Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. + Ensures that corrective measures meet acceptable reliability standards. + Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. + May develop mathematical models to identify units, batches or processes posing excessive failure risks. + As necessary, proposes changes in design or formulation to improve system and/or process reliability. + May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.Must Have: Minimum RequirementsTo be considered for this role, please ensure the minimum requirements are evident on your resume.Bachelors degree in Engineering, Science or Technical field with 4+ years of experience in Quality and/or Engineering or Advanced degree in Engineering, Science or technical field with 2+ years of experience in Quality and/or Engineering.Nice to Have+ Experience in Medical Device industry and Design Assurance + Experience with 21CFR820, ISO 13485, ISO 14971, and IEC 62366 + Knowledge of EUMDR, GMP, ISO, QSR and other applicable international regulations, standards, directives and guidance + Good statistical data analysis skills + Able to work independently, as well as in a team environment + Proficient with Microsoft Excel, Word, PowerPoint, Project + Experience with requirements management, version control, and issue tracking tools + Knowledge of Minitab desired + Must possess strong analytical problem-solving skillsAbout MedtronicTogether, 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. Lets 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) Less than 10% domestic and international travel. 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.

Keywords: Medtronic, Santa Rosa , Sr Reliability Engineer (Santa Rosa, CA, Galway Ireland or Remote with US), Other , Santa Rosa, California

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