Design Technician III - Remote

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timePosted 5 days ago location United States salarySalary undisclosed
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Job Description

Careers that Change LivesA Day in the Life Responsibilities may include the following and other duties may be assigned. Designs components or portions of systems and modifies existing designs to develop or improve products and facilitate manufacturing and field service operations. Utilizes computer-aided design equipment and/or graphic tools, such as CAD, CAM, CATIA, ProEngineer, Solidworx or Siemens NX Software. Gathers information, makes studies, computes calculations, and prepares original rough layouts, sketches to present design proposal. Coordinates design criteria with engineering, manufacturing, tooling, material, and planning group such as ease of manufacture, availability of materials, and contractual specifications. SUMMARY OF POSITIONThe candidate will support the Customer Quality Experience Management Analytics and Investigations team members' activities for the Gastrointestinal (GI)and Lung Health Divisions.These activities include; Training and supporting investigations team members on performing and documenting failure analysis on clinically applied medical device customer returns to ensure high levels of quality, reliability, safety, and efficacy, MDR (Medical Device Reporting) /AE (Adverse Event) reporting A review of the FDA MAUDE database for complaints involving Medtronic GI and Lung Health products, and assisting in implementing Continuous Improvements identified through Lean/Six Sigma tools. This will include quality monitoring of completed investigations and follow-up discussions with investigators for required elements for documenting investigation results. Continuous Improvement projects will entail Standard Work Instructions in support of training and additional training sessions as required. Additional responsibilities include management of clinically applied medical device retains and associated paper records in accordance with Medtronic Record Retention Policies and support staffing needs. ESSENTIAL FUNCTIONS:The following functions will be performed under direct supervision; Quality checks of completed investigation documentation within the complaint file for GIS/ILS to assure that compliance requirements are met. Review reports of corrections required and complaint backlog at a minimum of once weekly. Follow-up training/reviews of documentation with investigators as needed. Complaint database training for new hire investigators Assist with investigation backlog when able Familiarity with evaluation of Gastrointestinal and Lung Health devices to understand root cause analysis Represent GI & Lung Health on investigation related projects and activities. Knowledge of the appropriate visual and functional test method/regiment from existing Standard Operating Procedures for complaint product evaluation, execute the method, and interpret the data (technical) for definitive root cause analysis determination. Test methods may include Job Posting Tools 2 dimensional and/or tensile testing and interpretation of the technical data yielded in accordance with USP/EP/ASTM standards Assist with Initiation and distribution of Corrective Action Requests to Manufacturing or Engineering Departments as needed Advise on preparation of technical investigation reports based on results of evaluation and/or review of the manufacturing plant reports to be documented in the complaint database and incorporated into customer response letters Certification with OSHA's BloodBorne Pathogens Standard 29 CFR 1910.1030 Maintain the highest level of compliance to the Code of Federal Regulations, Medical Device Directive (European Union), Canadian Medical Device Regulations, Japan MHLW, China SFDA and Australian Regulations Must Have: Minimum Requirements Minimum of 4 years of experience of relevant experience and may require vocational or technical education or certification in addition to prior work experience Must be available to work at least 40 hours a week Nice to Have Experience in a laboratory environment and with laboratory equipment or Academic knowledge in scientific research methods Experience with medical devices preferred but not required • Knowledge of quality control concepts desirable Must be proficient with MS Office (with emphasis on Excel and PowerPoint) Experience writing and reading code (C++) preferred but not required Must have knowledge in using electronic/electrical tools Time management skills • Critical independent thinking and timely follow up Excellent written and verbal skills necessary to include technical writing Project management skills required • Ability to work with a global team High School Diploma required BS Degree in a technical curriculum or equivalent 4 years industry experience preferred but not required About 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. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe 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)