We anticipate the application window for this opening will close on - 20 Oct 2025

 

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.

A Day in the Life

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 shape the future of Design Controls procedures for the Cardiac Ablation Solutions (CAS) Operating Unit. The position will be the primary Product Quality individual contributor 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.  

 

Primary Responsibilities 

• 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. 

• Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives. 

• 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. 
   

Required Qualifications 

• Requires a Baccalaureate degree and minimum of 4 years of relevant experience  

• OR Master's degree with a minimum of 2 years relevant experience  

• OR PhD with 0 years relevant experience 

 

Preferred Qualifications 

• Thorough 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 owning or managing a QMS procedure/process 

• Additional product Reliability responsibilities may be included, primarily focused on Affera Capital (HW) equipment DRM, change man