Principal Reliability Engineer
Nice to Have
- Experience in the development of disposable medical devices as well as capital equipment.
- Experience in a highly-regulated industry, preferably implantable or cardiac medical devices
- Experience working with contract manufacturers and suppliers
- Strong understanding and experience in the application of statistics.
- Excellent problem solving skills, including demonstrated application of structured problem solving methods and tools
- Understanding of the product development process including methods for determining design inputs, evaluating multiple designs, and designing, executing the appropriate verification and validation tests, completing risk management deliverables, gaining internal and regulatory approval and launching new products.
- Knowledge of heart anatomy and atrial fibrillation disease types a plus as is experience with RF ablation surgical or catheter based medical devices
- DRM expertise with working knowledge in multiple DRM practices and demonstrated ability to use DRM tools.
- Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
- Knowledge of common applicable standards for ablation systems like 60601-1 (electrical safety), 14971 (risk mgmt.) and 10555 (intravascular catheters).
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)
Travel up to 10%
