Reliability Engineer II

Medtronic•Mounds View, MN

5d•$84,800 - $127,200•Hybrid

About The Position

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 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.

Requirements

Bachelor's degree and a minimum of 2 years of relevant experience OR Master’s degree with a minimum of 0 years of relevant experience
Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).

Nice To Haves

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

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.
Additional product Reliability responsibilities may be included, primarily focused on Affera Capital (HW) equipment DRM, change management, risk management, and risk response.