Senior Reliability Engineer

• ◆Support reliability and engineering activities to analyze, debug, and recommend design or process changes that improve system and process reliability
• ◆Assist with risk analysis studies of designs and processes to understand how potential quality issues may contribute to product quality or patient safety risk
• ◆Author or support the preparation of risk assessments, technical reports, and documentation of analysis results or quality impact; May fulfill the role of “Personnel with Clinical Knowledge” in risk management assessments if specialized skill criteria is met
• ◆Support verification and validation of device system requirements, including traceability and testability
• ◆Conduct or support evaluation of finished product systems, including requirements, design, development, documentation, integration, test, verification, and validation
• ◆Interpret and decompose system and product

and verify compliance with applicable standards and specifications

• ✓Collaborate with cross-functional partners to help investigate quality issues and support corrective actions
• ✓Analyze product performance data and summarize findings to support post-market surveillance and product improvement activities

• ✓Understanding of CRM products and their use in the clinical environment
• ✓Experience in reliability engineering or risk management
• ✓Clinical field experience utilizing CRM products
• ✓Experience in root cause investigations and assessing the risk impact of proposed design changes
• ✓Experience with 21 CFR 820, ISO 13485, and ISO 14971
• ✓Ability to evaluate and debug electrical designs, including RF performance
• ✓Experience with design, verification, and validation of Class III medical devices or similar regulated products
• ✓Demonstrated ability to perform data analysis using statistical techniques and reliability tools

• ✓Bachelor’s degree in Engineering, Science, or a technical discipline AND 4+ years of related work experience OR 2+ years of related work experience with an advanced degree

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the

of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job

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

and skills of this position.

The physical demands described within the

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

that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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