Sr Reliability Engineer

BioCT Innovation Commons; North Haven, Northern (CT, KY); Hybrid; USD 107,000 - 161,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Medtronic is seeking a Sr. Reliability Engineer to join the surgical operating unit within the new product development quality team. This role focuses on reliability strategies for medical devices, with emphasis on design controls and regulatory compliance.

The position involves cross-functional collaboration, writing reliability plans, conducting HALT/ALT tests, and developing test plans and reports to support product development and post-market reliability analyses.

Qualifications

• Bachelor’s degree with 4+ years of reliability engineering
• Master’s degree with 2+ years of reliability engineering or PhD with 0 years
• ASQ CRE and AAMI design control certifications are preferred

Responsibilities

• Participate in cross-functional development teams to provide reliability expertise
• Write reliability plans and identify activities to meet reliability objectives
• Perform HALT, ALT and other reliability tests
• Develop test plans, protocols and reports for verification/validation
• Collaborate with R&D for reliability testing to identify design weaknesses
• Support material and component selections to meet reliability requirements
• Conduct reliability predictions, modeling, and data analysis
• Provide post-market reliability support and analyze field data
• Ensure compliance with FDA and ISO/IEC standards
• Maintain thorough documentation of reliability activities

Skills

Reliability engineering

Regulatory compliance

Problem solving

Communication skills

Leadership

ASQ CRE

AAMI design control

Education

Bachelor's in Mechanical/Electrical Engineering or Reliability Engineering

Master's in Mechanical/Electrical or Reliability Engineering

PhD in a related field

Tools

ReliaSoft

LabVIEW

Sherlock

Job description

We anticipate the application window for this opening will close on - 31 Aug 2026

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 Sr. 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 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.

Primary 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 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.

Other potential responsibilities

• 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.

Must Have: Minimum Requirements

• Bachelor’s Degree in Mechanical/Electrical Engineering or Reliability Engineering or similar engineering degree with 4+ years of experience in Reliability Engineering
• Master’s Degree in Mechanical/Electrical or Reliability Engineering or similar engineering degree with 2+ years of experience in Reliability Engineering OR PhD with 0 years relevant experience.

Preferred Qualifications

• 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
• Certifications: ASQ Certified Reliability Engineer (CRE), design for reliability and manufacturing, Six Sigma Green Belt or equivalent certification,
• AAMI design control certification.
• Experience: Reliability engineering field
• Industry Experience: Medical device/Automotive/Aerospace industry.
• Technical Skills: Proficient in quality management systems, risk management, regulatory compliance, and statistics.
• Tools: 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 workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

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.

Salary ranges for U.S (excl. PR) locations (USD):$107,200.00 - $160,800.00

• 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
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.