Senior Reliability Engineer

Medtronic; Mounds View (MN); Hybrid; USD 107,000 - 161,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with company match

Employee stock purchase plan

Job summary

Medtronic plc in Minnesota seeks a Senior Reliability Engineer to support post-market surveillance for implantable devices. You will analyze performance data, support risk assessments, and help investigate quality issues to improve product reliability for pacemakers, defibrillators, and leads.

The role requires strong background in reliability, risk management, and regulatory standards (21 CFR 820, ISO 13485, ISO 14971). Hybrid on-site work in Mounds View, MN with 4+ days/week onsite.

Qualifications

• Bachelor’s degree in engineering, science, or a technical discipline with 4+ years of related experience, or 2+ years with advanced degree.
• Experience in reliability engineering or risk management.
• Experience with 21 CFR 820, ISO 13485, and ISO 14971.
• Experience with Class III medical devices, RF or regulatory requirements.

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.

Skills

Reliability engineering

Risk management

Root cause investigations

Data analysis

Education

Bachelor’s degree in engineering/science/technical discipline

Advanced degree (MS/PhD)

Job description

A Day in the Life

The Senior Reliability Engineer 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.

The EPT DS operating unit offers high power devices and therapies to treat abnormal heart rhythms.

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.

Primary 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

Preferred Qualifications

• 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

Required Qualifications

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

Physical Job Requirements

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 responsibilities and skills of this position.

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.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$107,200.00 - $160,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, andSimple Steps (global well‑being program).

The following benefits and additional compensation are available to all regular employees: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), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.