Sr. Reliability Engineer (Stapling Portfolio / Surgical)
About The Position
The Sr. Reliability Engineer supports the quality and reliability of Medtronic’s Core Surgical Innovations (CSI) Stapling portfolio throughout the product lifecycle. The portfolio includes software-enabled surgical systems integrating mechanical design, embedded software, electronics, and circuit board technologies. The engineer serves as the quality and reliability lead for assigned products, investigating complex performance issues, identifying failure mechanisms, and applying analytical techniques to improve product performance and reduce risk. The role partners with Research & Development, Supplier Quality, Manufacturing, and Complaint Handling teams to address technical challenges and inform product decisions. Work includes reliability programs, laboratory investigations, statistical analysis, risk management, design-change evaluation, and analysis of complaint and quality-system data. The position is based in North Haven, Connecticut and requires at least four days per week onsite to support laboratory testing, product investigations, and collaboration.
Requirements
- Bachelor's degree with 4+ years of relevant experience, or a Master's degree with 2+ years of relevant experience, or a PhD.
- Experience in medical device, pharmaceutical, biotechnology, or another regulated product industry.
- For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- For roles below Principal level, candidates must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
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 the 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 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 issues; identify failure mechanisms, determine root causes, and drive corrective actions.
- Apply statistical methods such as Design of Experiments (DOE), regression analysis, confidence intervals, hypothesis testing, and trend analysis to support engineering decisions.
- Partner with Research & Development 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 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 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 for 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
