Reliability Engineer II

We anticipate the application window for this opening will close on - 2 Jan 2026

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross‑functional collaboration as we work together to engineer the extraordinary.

This role will have an exciting opportunity to help shape the future of Design Controls procedures for the Cardiac Ablation Solutions (CAS) Operating Unit. The position will be responsible for developing, managing, and executing QMS procedure re‑writes to harmonize CAS Design Control procedures. This individual will report directly to the Sr. Manager for Affera Capital (HW) Reliability Engineering team and DC Harmonization project leader.

• Develops, coordinates and 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 risk analysis studies of new design and 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.

• May develop mathematical models to identify units, batches or processes posing excessive failure risks.

• As necessary, proposes changes in design or formulation to improve system and/or process reliability.

• May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

• Requires a Baccalaureate degree and minimum of 2 years of relevant experience.

• Or Master’s degree with a minimum of 0 years 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 21
  
  CFR
  820, ISO
  13485, and ISO
  14971.

• 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.

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.

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…