Sr. Reliability Engineer (Stapling Portfolio / Surgical)
Medtronic · North Haven, CT
- Level
- Senior
- Team
- Reliability
- Base pay
- $107k–$161k
- Degree
- Required
- Experience asked
- 4+ years
- Industry
- Medical devices
- Posted
- 3 days ago
The role in 30 seconds
A senior reliability role at Medtronic (medical devices) in North Haven, CT. In partnership with Research & Development, Supplier Quality, Manufacturing, and Complaint Handling teams, you'll help solve complex technical challenges and guide decisions that improve product performance and patient outcomes.
- They ask for
- 4+ years · degree required
- Tools it names
- Root cause, FMEA, DOE, Minitab, ISO 13485, Validation (IQ/OQ/PQ)
- Base pay
- $107k–$161k
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About the role
Responsibilities
- ◆Lead reliability engineering programs including reliability demonstration testing, accelerated life testing, reliability growth initiatives, predictive modeling, and test planning.
- ◆Investigate product performance, field quality, and manufacturing-related issues to identify failure mechanisms, determine root causes, and drive effective corrective actions.
- ◆Apply statistical methods including Design of Experiments (DOE), regression analysis, confidence intervals, hypothesis testing, and trend analysis to support engineering decisions.
- ◆Partner with Research & Development teams to evaluate design changes, improve product robustness, and support verification, validation, and design review activities.
- ◆Conduct hands-on product evaluations, laboratory investigations, and technical assessments to understand product performance and validate engineering hypotheses.
- ◆Lead risk management activities including hazard analysis, Failure Modes and Effects Analysis (FMEA), risk assessments, and maintenance of risk management documentation.
- ◆Review and assess engineering, supplier, and manufacturing changes to ensure quality, reliability, and regulatory
requirements
are met.
- ✓Analyze complaint, post-market, and quality system data to identify emerging trends and drive product and process improvements.
Required Qualifications
- ✓Bachelor's degree with 4+ years of relevant experience OR Master's degree with 2+ years of relevant experience OR PhD.
- ✓Experience in medical device, pharmaceutical, biotechnology, or other regulated product industries.
Preferred Qualifications
- ✓Experience with design controls, risk management, verification, validation, and engineering change processes.
- ✓Experience supporting embedded software, electronic hardware, circuit board-based, or electromechanical products .
- ✓Experience conducting root cause investigations and resolving product or process quality issues.
- ✓Experience applying statistical methods to product, reliability, quality, or process improvement activities.
- ✓Knowledge of ISO 13485, ISO 14971, IEC 60601, and European Union Medical Device Regulation (EU MDR).
- ✓Experience with reliability methodologies including accelerated life testing, reliability demonstration testing, predictive modeling, and reliability growth analysis.
- ✓Experience using Minitab for Design of Experiments (DOE), regression analysis, confidence intervals, hypothesis testing, and statistical modeling.
- ✓Experience applying structured problem-solving methods including Fault Tree Analysis, Fishbone Analysis, 5 Why investigations, and failure mechanism analysis.
- ✓Experience leveraging artificial intelligence tools to enhance engineering analysis, data evaluation, or technical problem solving.
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
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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
Core Surgical Innovations (CSI) develops advanced surgical technologies that help clinicians deliver safe, effective care across a broad portfolio of minimally invasive and open surgical procedures. The CSI Stapling portfolio includes sophisticated electromechanical and software-enabled surgical systems that integrate mechanical design, embedded software, electronics, and circuit board technologies to support critical surgical procedures worldwide.
The Sr. Reliability Engineer supports the quality and reliability of advanced stapling technologies throughout the product lifecycle, leading activities ranging from risk assessments and design changes to failure investigations and reliability improvements.
This role offers the opportunity to work with software-enabled products, embedded systems, and electronic hardware, making it well suited for engineers with experience in embedded software, circuit board technologies, or complex electromechanical systems. In partnership with Research & Development, Supplier Quality, Manufacturing, and Complaint Handling teams, you'll help solve complex technical challenges and guide decisions that improve product performance and patient outcomes.
This position is based in North Haven, Connecticut, with a minimum of four days per week onsite to support laboratory testing, product investigations, and cross-functional collaboration.
As a Senior Reliability Engineer, you will serve as the quality and reliability lead for products within the CSI Stapling portfolio. You will investigate complex product performance issues, identify failure mechanisms, and apply advanced analytical techniques to drive product improvements and reduce risk. Working closely with Research & Development, Manufacturing, and Supplier Quality teams, you will influence decisions across the product lifecycle through hands-on investigations, data-driven analysis, and design quality expertise.
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