Reliability Engineer II

Medtronic•Mounds View, MN

5d•$84,800 - $127,200•Hybrid

About The Position

The Reliability Engineer II will support key technical activities within the Electrophysiology Therapies (EPT) Defibrillation Solutions (DS) Post Market Quality organization. This role will contribute to post-market surveillance activities by analyzing product performance data, supporting risk assessments and technical documentation, and helping investigate quality issues to improve product performance for implantable products such as pacemakers, defibrillators, and leads. This position will be based at our Mounds View, MN facility and follows a hybrid work model requiring a minimum of 4 days per week on-site for in-person collaboration and project activities.

Requirements

Bachelor’s degree in Engineering, Science, or a technical discipline
Minimum of 2 years of work experience in Engineering, Science, or a related technical field OR Minimum of 0 years of work experience with an advanced degree in Electrical Engineering, Engineering, Science, or a related technical discipline
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
The employee is also required to interact with a computer, and communicate with peers and co-workers.
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.

Nice To Haves

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

Responsibilities

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 requirements 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

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)