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 MDR Vigilance specialist I Careers that Change Lives Review evaluate classify and perform follow up activities on all product complaints relative to the identity quality reliability safety and effectiveness of medical devices Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury Write Investigation Summaries based on technical product analysis information provided by the plant A Day in the Life Write Investigation Summaries based on technical product analysis information provided by the plant Must Have Job Responsibilities Evaluates incoming complaint information and maintains the record in the electronic database Performs follow up activities to obtain additional information Use and maintain database s provide analysis and trending data all on complaints Determines Reportability of complaints to Government Agencies Identify and document appropriate complaint categories to assure trend accuracy within the complaint database Writes investigation summaries based on technical product analysis information provided Ensures record documentation is maintained in a constant state of audit readiness per internal policies Liaison with groups who perform additional investigation and who prepare written record of investigation Interact with Technical Service Manufacturing R D and Quality Assurance as needed during the course of complaint processing Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations Reviews and interprets risk management documentation as it applies to the complaint event Interacts with multiple departments within Medtronic - MITG such as Technical Services Failure Investigation R D Manufacturing and Engineering Interacts with groups external to Medtronic - MITG such as customers vendors health care professional Minimum Qualifications Bachelor degree Engineering or Science degrees preferred e g EE ME Biomedical Engineering 1 to 3 years quality assurance or regulatory experience in medical or pharmaceutical industry Computer literate with skills in Word Excel Access PowerPoint and database trending analysis Strong typing skills and ability to write business documents with minimal supervision Strong verbal and written communication skills and ability to work in a team oriented setting Ability to multitask Ability to understand the functionality intended use of complex medical devices Minimum travel may be required Nice to Haves Knowledge of medical devices their development and quality control Knowledge of FDA MEDDEV Canadian Regulations Technical Writing experience 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 Whatever your specialty or ambitions you can make a difference at Medtronic - both in the lives of others and your career Join us in our commitment to take healthcare Further Together Responsibilities may include the following and other duties may be assigned This is a temporary position Responsible for performing and supporting research for teams operating within a service group or product group and or project group Assists with the development monitoring coordination and implementation of technical projects as assigned Provides analysis reporting and internal communication services with team members Develops knowledge of industry and organizational processes SPECIALIST CAREER STREAM Typically an individual contributor with responsibility in a professional discipline or specialty Delivers and or manages projects assigned and works with other stakeholders to achieve desired results May act as a mentor to colleagues or may direct the work of other lower level professionals The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies using specialized knowledge and skills normally acquired through advanced education DIFFERENTIATING FACTORS Autonomy Entry-level individual contributor on a project or work team Works with close supervision Organizational Impact Delivers work of limited scope typically smaller less complex projects or related activities Innovation and Complexity Identifies defines and addresses problems that are not immediately evident but typically not difficult or complex Makes minor changes in systems and processes to solve problems Communication and Influence Communicates primarily with internal contacts within immediate group Contacts others to gather confirm and convey information Leadership and Talent Management N A - job at this level is focused on self-development Required Knowledge and Experience Requires broad theoretical job knowledge typically obtained through advanced education Requires a Baccalaureate degree or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C F R 214 2 h 4 iii A 0 years of experience required 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