Senior Reliability Engineer, Surgical Stapling Systems

Medtronic plc; North Haven (CT); On-site; USD 107,000 - 161,000; Full time

Job summary

Medtronic is seeking a Senior Reliability Engineer in North Haven, CT, to lead quality and reliability efforts across the CSI Stapling portfolio. You will guide investigations, perform data-driven analyses, and manage risk throughout the product lifecycle.

The role emphasizes embedded software, circuit-board technologies, and electromechanical systems, with a focus on designing robust, regulatory-compliant medical devices and collaborating with cross-functional teams in R&D, manufacturing, and

Qualifications

• Bachelor's degree with 4+ years of relevant experience or higher.
• Experience in medical device or regulated industries.
• Preferred knowledge of ISO13485, ISO14971, IEC60601, and EU MDR.

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 and drive corrective actions.
• Apply statistical methods including DOE, regression analysis, confidence intervals, hypothesis testing, and trend analysis to support decisions.
• Partner with R&D to evaluate design changes, improve product robustness, and support verification, validation, and design reviews.
• Conduct hands-on product evaluations, laboratory investigations, and technical assessments to understand performance and validate hypotheses.
• Lead risk management activities including hazard analysis, FMEA, risk assessments, and maintenance of documentation.
• Review engineering, supplier, and manufacturing changes to ensure quality and regulatory compliance.
• Analyze complaint and post-market data to identify trends and drive improvements.

Skills

DOE

Regression analysis

Hypothesis testing

FMEA

Design controls

Embedded software

Circuit boards

Statistical modeling

Education

Bachelor's degree in engineering or related field

Master's degree in related field

PhD

Tools

Minitab

Job description

Medtronic is seeking a Senior Reliability Engineer in North Haven, CT, to lead quality and reliability efforts across the CSI Stapling portfolio. You will guide investigations, perform data-driven analyses, and manage risk throughout the product lifecycle.

The role emphasizes embedded software, circuit-board technologies, and electromechanical systems, with a focus on designing robust, regulatory-compliant medical devices and collaborating with cross-functional teams in R&D, manufacturing, and