Onsite Senior Reliability Engineer – Surgical Stapling Systems

BioCT Innovation Commons; North Haven (CT); On-site; USD 107,000 - 161,000; Full time

Benefits offered by this job

Health, Dental and vision insurance

Health Savings Account

Healthcare Flexible Spending Account

Life insurance

401(k) plan plus employer match

Paid time off

Paid holidays

Employee Stock Purchase Plan

Employee Assistance Program

Tuition assistance/reimbursement

Job summary

Medtronic’s Core Surgical Innovations (CSI) division in North Haven, CT, is seeking a Senior Reliability Engineer to lead product reliability across the stapling portfolio. You will manage risk assessments, FMEA, and design changes, partnering with R&D, Manufacturing, and Supplier Quality to improve performance and patient outcomes.

The role requires a BS with 4+ years in medical devices or related regulated industries; familiarity with DOE, statistical methods, and design controls; embedded

Qualifications

• Bachelor's degree with 4+ years of relevant experience or higher.
• Experience in medical device, pharmaceutical, biotechnology, or other regulated product industries.
• Experience with design controls, risk management, verification, validation, and engineering change processes.

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.

Skills

Reliability engineering

Statistical methods

DOE

Risk assessment

Root cause analysis

Education

Bachelor's degree in a relevant field

Master's degree

PhD

Tools

Minitab

Job description

Medtronic’s Core Surgical Innovations (CSI) division in North Haven, CT, is seeking a Senior Reliability Engineer to lead product reliability across the stapling portfolio. You will manage risk assessments, FMEA, and design changes, partnering with R&D, Manufacturing, and Supplier Quality to improve performance and patient outcomes.

The role requires a BS with 4+ years in medical devices or related regulated industries; familiarity with DOE, statistical methods, and design controls; embedded