Reliability Engineer II

MedtronicMounds View, MN
1d$84,000 - $126,000Onsite

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 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.

Requirements

  • Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience

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

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.
  • 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.

Benefits

  • 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.
  • 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).
  • 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).
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