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Medtronic

Medical device maker advancing therapies

Reliability Engineer 2

Biomedical Engineering & Medical DevicesPosted on Nov 12
Full-timeMounds View, MN, USA

About the Job

Requirements

  • A baccalaureate degree in Science, Technology, Engineering, or Math is required.
  • At least 2 years of relevant experience is required, or a Master's degree with at least 0 years of relevant experience.
  • Demonstrate strong written and verbal communication skills.
  • Be able to determine whether further action is needed or document defensible rationales, considering impacts to the product, patient, and program.
  • Be able to resolve conflicts.

Responsibilities

  • Assess new component and product designs for potential risk impacts, including requirement, drawing, and bill of materials reviews.
  • Generate, review, and approve design failure mode and effects analyses.
  • Create design verification protocols and test reports in compliance with medical device design control procedures.
  • Collaborate with cross-functional teams to resolve technical issues.
  • Execute testing and analyze reliability data from design characterization to identify and resolve potential issues with components, interfaces, and product systems.
  • Create new test methods based on product requirements, order equipment, design fixtures, execute test method validation, and release work instructions and test method validation reports.
  • Support risk assessments and hazard analyses based on predicate product and post-market data.
  • Update risk management files for design and manufacturing issues.
  • Lead investigations into product failures using root cause analysis techniques to determine underlying causes.
  • Implement technical learnings into improved product design and risk management.
  • Collaborate with design, manufacturing, and quality teams to implement design, process, or supplier changes and corrective and preventive actions that enhance product reliability.
  • Support Supplier Quality and Manufacturing teams in risk-based decisions for supplier selection, Quality Impact Assessment, and test methods.
  • Support knowledge transfer to post-market Quality, Returned Products Analysis, and Complaints Trending.

Desired Qualifications

  • Prior experience in the medical device industry across product development, operations, or quality functions.
  • Demonstrated expertise in risk management in accordance with ISO 14971.
  • Strong technical writing and communication skills, with the ability to clearly explain complex technical topics to non-technical audiences.
  • Proven ability to lead root cause investigations, solve complex technical problems, and perform statistical data analysis.
  • Knowledge of Microsoft Office applications, including Word, Excel, and PowerPoint, and Windows operating system.
  • Familiarity with ISO 13485, IEC 60601, and geometric dimensioning and tolerancing.

About the Company

Medtronic

Medical device maker advancing therapies

Medtronic develops medical devices that diagnose, monitor, and treat chronic diseases. Its products include implantables, sensors, and therapies used in cardiovascular care, diabetes management, and neurostimulation, working by interacting with the body to regulate or monitor physiological processes. The company differentiates itself through a long history of device development, strategic acquisitions like Covidien, and a broad, diversified portfolio across therapeutic areas. Its goal is to improve patients’ health outcomes by delivering integrated medical technologies and solutions for disease management.

Company size
10,001+
Company stage
IPO
Headquarters
Fridley, MN
Founded
1949

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