Sr. Reliability Engineer (Stapling Portfolio / Surgical)
About The Position
The Sr. Reliability Engineer serves as the quality and reliability lead for products in Medtronic’s Core Surgical Innovations (CSI) Stapling portfolio, which includes electromechanical and software-enabled surgical systems combining mechanical design, embedded software, electronics, and circuit board technologies. The role supports product quality and reliability throughout the lifecycle, leading risk assessments, design-change evaluations, failure investigations, and reliability improvements. It is suited to engineers with experience in embedded software, circuit board technologies, or complex electromechanical systems. The engineer works cross-functionally with Research & Development, Supplier Quality, Manufacturing, and Complaint Handling teams to investigate technical challenges and inform decisions that improve product performance and patient outcomes. The work includes hands-on laboratory testing and product investigations, reliability and statistical analysis, root-cause investigations, risk management, and support for verification, validation, and design review activities. The position is based in North Haven, Connecticut, and requires a minimum of four days per week onsite. The role requires a bachelor’s degree and at least four years of relevant experience, a master’s degree and at least two years of relevant experience, or a PhD, as well as experience in a regulated industry such as medical devices, pharmaceuticals, or biotechnology. The position is eligible for the Medtronic Incentive Plan. The listed U.S. salary range is $107,200 to $160,800.
Requirements
- Bachelor’s degree with at least 4 years of relevant experience, or a master’s degree with at least 2 years of relevant experience, or a PhD.
- Experience in medical device, pharmaceutical, biotechnology, or another regulated product industry.
Nice To Haves
- 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.
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 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.
Benefits
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Tuition assistance/reimbursement.
- Global well-being program (Simple Steps).
- Incentive plans.
- 401(k) plan with 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
