Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeEngineering ManagerCareers that Change LivesReview, 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 LifeWrite Investigation Summaries based on technical product analysis information provided by the plant.Must HaveJob ResponsibilitiesProvide leadership to a team that handles complaintsEvaluate strategy to transform operations and look for continuous improvementsEvaluates 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 professionalMinimum QualificationsBachelor degree; Engineering or Science degrees preferred (e.g. SW,EE, ME, Biomedical Engineering)18+ years quality assurance or regulatory experience in medical or pharmaceutical industry.Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysisStrong 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 environmentAbility to be proactive and lead initiatives technicallyAbility to multitask.Ability to understand the functionality / intended use of complex medical devices.Minimum travel may be requiredNice to HavesKnowledge of medical devices, their development and quality control.Knowledge of FDA, MEDDEV, Canadian Regulations.Technical Writing experience.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.Lets 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.Physical 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 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.
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 90,000+ 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.Learn more about our business, mission, and our commitment to diversity

Medtronic