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Principal Reliability Engineer

Medtronic · North Haven, CT

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Level
Senior
Team
Reliability
Base pay
$132k–$198k
Degree
Required
Experience asked
7+ years
Certification
Green Belt preferred
Industry
Medical devices
Posted
Today

The role in 30 seconds

A senior reliability role at Medtronic (medical devices) in North Haven, CT. Support R&D in selecting materials and components to achieve defined reliability and performance requirements.

They ask for
7+ years · degree required · Green Belt preferred
Tools it names
Six Sigma, Green Belt, Root cause, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ)
Base pay
$132k–$198k

Read from the posting. The full description is below.

It asks for 7+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

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About the role

requirements

is preferred. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This role will be pivotal in ensuring the development of medical devices that meet reliability requirements.

Responsibilities

may include the following, as well as other duties that may be assigned.

  • ◆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 that includes HALT, ALT and other discovery tests
  • ◆Support test method validation and verification activities, including the development and approval of test plans, protocols, and final reports.
  • ◆Collaborate with R&D to design and implement mechanical and/or electrical reliability tests to 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 de-rating analysis as applicable
  • ✓Conduct reliability predictions, modeling and data analysis to assess product reliability and risk
  • ✓Provide post-market reliability engineering support, including analysis of field performance and failure data
  • ✓Ensure compliance with applicable regulatory and industry standards, including FDA

requirements

and ISO/IEC standards (e.g., 14971, 13485, 62304, FDA Part 820, IEC 60601).

  • ✓Maintain thorough, accurate, and compliant documentation of all reliability engineering activities, including test data, analyses, and reports.
  • ✓Lead and mentor teams in the development, implementation, and maintenance of the reliability processes and standards.
  • ✓Partnering 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.

Required Knowledge and Experience

  • ✓Bachelor’s Degree in Mechanical/Electrical Engineering or Reliability Engineering or similar engineering degree with 7 years of relevant experience OR a Master’s degree in Mechanical/Electrical or Reliability Engineering or similar engineering degree with 5 years of relevant experience.

Preferred Qualifications

  • ✓ASQ Certified Reliability Engineer (CRE), design for reliability and manufacturing, Six Sigma Green Belt or equivalent certification,
  • ✓AAMI design control certification.
  • ✓Experience in Reliability engineering field.
  • ✓Regulatory Knowledge: In-depth knowledge of regulations and other relevant standards.
  • ✓Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
  • ✓Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
  • ✓Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously. Able to work independently
  • ✓Industry Experience: Medical device/Automotive/Aerospace industry.
  • ✓Technical Skills: Proficient in quality management systems, risk management, regulatory compliance, and statistics.
  • ✓ReliaSoft software experience
  • ✓LabVIEW experience
  • ✓Sherlock experience.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the

requirements

of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job

Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required

responsibilities

and skills of this position.

The physical demands described within the

Responsibilities

section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical

requirements

that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workf

Show full description ↓

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Principal Reliability Engineer to join our innovative team. This role will be in the surgical operating unit within the new product development quality team. The ideal candidate will bring a strong background in reliability science, with demonstrated experience developing reliability strategies for new products, including reliability planning and testing. This role also supports medical device product development, and a solid understanding of design controls and regulatory compliance

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