Medtronic

Mechanical Reliability Engineer II

Medtronic

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $84,800 - $127,200 per year

Job Level

JuniorMid-Level

About the role

  • Collaborates with cross-functional teams to develop and release new cardiac rhythm management products and design changes.
  • Plans, leads, and integrates Design for Reliability (DfR) activities on product development projects to drive product safety, complaint reduction, reliability, and quality outcomes.
  • Evaluates designs for potential failure modes, assesses potential hazards and harms, prioritizes safety risks, identifies appropriate risk controls, and compiles evidence to demonstrate benefits outweigh product risks.
  • Defines and allocates reliability requirements and goals, develops and leads reliability demonstration strategies, manages completion of reliability growth activities, and recommends design and manufacturing updates.
  • Understands legacy product performance and incorporates learnings into new product development projects.
  • Develops test plans, determines statistically valid sample sizes, works with test labs to demonstrate performance, addresses test observations, statistically analyzes data, and writes test reports.
  • Articulates risk management and reliability activities and conclusions in documentation, regulatory submissions, and audits.
  • Performs engineering reviews of quality records for safety and reliability impact.
  • Advocates for safety, reliability, and quality in design reviews and other project meetings.
  • This position is in Mounds View, MN. within the Cardiac Rhythm Management (CRM) operating unit.
  • In-person exchanges are invaluable to our work. We are working on-site 4 days per week 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 require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

Requirements

  • Bachelor’s degree required in engineering, math, science, or technical discipline
  • Minimum of 2 years of technical experience, or advanced degree with a minimum of 0 years technical experience
  • Implantable medical device industry experience (nice to have)
  • Advanced degree in Engineering or suitable Clinical/Field Support, Safety or Reliability Engineering, Biomedical Engineering, Mechanical Design Engineering, or Product Development Engineering experience (nice to have)
  • Knowledge of cardiac anatomy, physiology, and primary disease states (nice to have)
  • Experience with 21 CFR Part 820, ISO 13485, ISO 14971, and Hazard Analysis and Risk Analysis techniques (e.g., FTA, DFMEA)
  • Certification (belts) in Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices (nice to have)
  • ASQ CRE certified (nice to have)
  • Strong written and verbal communication skills
  • Ability to work cooperatively and influence outcomes as part of a cross-functional team
  • Ability to manage project timelines to execute tasks and deliverables in a timely manner