Senior Reliability Engineer
About The Position
The Senior Reliability Engineer supports technical activities within Medtronic’s Electrophysiology Therapies (EPT) Defibrillation Solutions (DS) Post Market Quality organization. The role contributes to post-market surveillance by analyzing product performance data, supporting risk assessments and technical documentation, and helping investigate quality issues to improve the performance of implantable products such as pacemakers, defibrillators, and leads. The EPT DS operating unit offers high-power devices and therapies for treating abnormal heart rhythms. The role is based at Medtronic’s Mounds View, Minnesota facility and follows a hybrid work model requiring at least four days per week on-site for in-person collaboration and project activities.
Requirements
- Bachelor’s degree in Engineering, Science, or a technical discipline and at least 4 years of related work experience, or an advanced degree and at least 2 years of related work experience.
- For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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 and debug systems and recommend design or process changes that improve reliability.
- Assist with risk analysis studies of designs and processes to understand potential effects of quality issues on product quality or patient safety.
- Author or support risk assessments, technical reports, and documentation of analysis results or quality impact; may serve as “Personnel with Clinical Knowledge” in risk management assessments if specialized skill criteria are 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, testing, verification, and validation.
- Interpret and decompose system and product requirements and verify compliance with applicable standards and specifications.
- Collaborate with cross-functional partners to investigate quality issues and support corrective actions.
- Analyze product performance data and summarize findings to support post-market surveillance and product improvement activities.
Benefits
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Tuition assistance or reimbursement.
- Simple Steps global well-being program.
- Incentive plans.
- 401(k) plan with 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
