Reliability Engineer II

Reliability Engineer II

Medtronic Cardiac and Vascular
2-5 years
Not Specified

Job Description

Careers That Change Lives
We are looking for a dynamic and adaptive Reliability Engineer II, with the desire to be part of the fast-growing Cardiac Ablation Solutions business, helping us to ensure they exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.
This position provides reliability engineering support on new development projects. The candidate will be a key player in cross-functional teams and serve as a compliance and technical representative for reliability, safety, and quality functions.
As part of R&D project teams, the Reliability Engineer II will contribute and execute to the quality plan for ensuring compliance to regulatory requirements. This position will work with multidisciplinary teams and provide guidance to technical issues, engagement in design and risk reviews, and contribute to development activities.
Cardiac Ablation Solutions
Cardiac Ablation Solutions provides a broad suite of electrophysiology solutions intended to disrupt and lead the market in cardiac mapping and ablation technologies for arrhythmia management. These clinical and economical solutions will enable clinicians to treat patients with safer, faster and easier, and with more predictable procedure times and outcomes.
A Day in the Life
  • Review mechanical drawings for consistency and clarity
  • Support the planning, execution, documentation, and approval of test method validation and design verification studies.
  • Review and modify risk analysis documentation to support design of new processes and products.
  • Ensure compliance with relevant safety regulations, QSRs, ISO Standards, EU MDR, MDD, Quality Business System and Key Corporate Policies
  • Review and approve changes to designs/processes and assess impact on product and qualification status
  • Providing input for Regulatory submissions
  • Responsible for addressing assigned CAPA activities and ensuring that established timelines are met
  • Responsibilities may also include the following and other duties may be assigned:
  • 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 Requirements
Bachelor's Degree in Engineering, Science, or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 0 years of work experience in Engineering and/or Quality
Nice to Have
  • Bachelor of Science in Mechanical Engineering
  • 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 is 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.
  • Knowledge of common applicable standards for ablation systems like 60601-1 (electrical safety), 14971 (risk mgmt.) and 10555 (intravascular catheters).

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 less than 10%

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