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Medtronic

Medical device maker advancing therapies

Principal Reliability Engineer

Biomedical Engineering & Medical DevicesUpdated on Nov 6
Full-timeNorth Haven, CT, USA$132k - $198kIn-person

About the Job

Requirements

  • A bachelor's degree in Mechanical Engineering, Electrical Engineering, Reliability Engineering, or a similar engineering degree with 7 years of relevant experience, or a master's degree in one of those fields or a similar engineering degree with 5 years of relevant experience.
  • For baccalaureate degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
  • A strong background in reliability science and demonstrated experience developing reliability strategies for new products, including reliability planning and testing.
  • A solid understanding of design controls and regulatory compliance requirements is preferred in the role description.
  • Strong analytical and problem-solving skills, including the ability to conduct thorough root cause analysis.
  • Written and verbal communication skills sufficient to collaborate with cross-functional teams and present complex information to stakeholders.
  • Knowledge of quality management systems, risk management, regulatory compliance, statistics, and relevant regulations and standards.

Responsibilities

  • Participate in cross-functional development teams, providing mechanical and/or electrical reliability engineering expertise.
  • Write reliability plans and identify reliability activities during product development to achieve company, customer, or agency reliability objectives.
  • Perform reliability testing, including HALT, ALT, and other discovery tests.
  • Support test method validation and verification activities, including developing and approving test plans, protocols, and final reports.
  • Collaborate with R&D to design and implement mechanical and/or electrical reliability tests that identify design weaknesses early in development.
  • Support R&D in selecting materials and components to achieve defined reliability and performance requirements.
  • Perform electrical and/or thermal derating analysis as applicable.
  • Conduct reliability predictions, modeling, and data analysis to assess product reliability and risk.
  • Provide post-market reliability engineering support, including analyzing field performance and failure data.
  • Ensure compliance with applicable regulatory and industry standards, including FDA requirements and ISO/IEC standards such as 14971, 13485, 62304, FDA Part 820, and IEC 60601.
  • Maintain thorough, accurate, and compliant documentation of reliability engineering activities, including test data, analyses, and reports.
  • Lead and mentor teams in developing, implementing, and maintaining reliability processes and standards.
  • Partner with software reliability and software development teams as part of mission reliability.
  • Collaborate with cross-functional teams to define and implement engineering and statistical processes that ensure product reliability and compliance throughout the product lifecycle.

Desired Qualifications

  • ASQ Certified Reliability Engineer (CRE), design for reliability and manufacturing, Six Sigma Green Belt, or equivalent certification.
  • AAMI design control certification.
  • Experience in the reliability engineering field.
  • Proven leadership and project management skills, including the ability to lead teams and manage multiple projects simultaneously; ability to work independently.
  • Industry experience in medical devices, automotive, or aerospace.
  • Experience with ReliaSoft software.
  • Experience with LabVIEW.
  • Experience with Sherlock software.

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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