Reliability Engineer II
Role details
Job location
Tech stack
Job description
This is an exciting opportunity to support the continued scaling and improvement of Affera HW system in the Cardiac Ablation Solutions (CAS) Operating Unit as a Reliability Engineer. The Affera system is a primary portfolio driver for the CAS OU with integrated mapping, navigation, RF, and PF functionality. This Reliability role is on the Affera HW REL team with full lifecycle scope and a focus on released product engineering and quality response. Primary responsibilities will include Design Change, Design Verification, Risk Management, OEM/CM Supplier Change support, and risk response (Issue Evaluation/PHO/HRA/FCA). The role will report to the Sr. Manager for Affera Capital (HW) Reliability Engineering team., * Develops,coordinatesand 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 riskanalysis studiesofnew designand 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,customerand governmental agency reliabilityobjectives.
- May develop mathematical models toidentifyunits,batchesor processes posing excessive failure risks.
- As necessary,proposeschanges in design or formulation to improve system and/or process reliability.
- Maydetermineunits and/or batchesrequiringenvironmentaltesting, andspecifiesminimum number of samples to obtain statistically valid data.
Requirements
- Bachelor's degree anda minimum of2years of relevant experience
- ORMaster'sdegree witha minimum of0years of relevant experience, * Medical Device Experience
- Understanding and experience in design controls, V&V, and Risk Management - both commercial and development.
- System-thinking and process mapping, ability to effectively identify interfaces, dependencies, and control points.
- Demonstrated ability in stakeholder management and coordinating complex assignments with cross-functional teams
- Understanding of 21CFR820, ISO13485, and ISO14971
- Experience managing a QMS procedure/process
- Additional product Reliability responsibilities may be included, primarily focused on Affera Capital (HW) equipment DRM, change management, risk management, and risk response
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.
Benefits & conditions
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.
Join us in our mission to alleviate pain, restore health, and extend life-where your unique background and perspective are valued.
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):$84,800.00 - $127,200.00
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, and Simple 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), and Capital 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.