Sr. Reliability Engineer (Stapling Portfolio / Surgical)

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.

Primary 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. *

• 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.

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

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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 , and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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) , and 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