Senior Reliability Engineer, Stapling Portfolio / Surgical

What you'll do

• Lead reliability engineering programs including reliability demonstration testing, accelerated life testing, and predictive modeling.
• Investigate product performance and manufacturing issues to identify failure mechanisms and determine root causes.
• Apply statistical methods such as Design of Experiments (DOE), regression analysis, and hypothesis testing to support engineering decisions.
• Partner with R&D teams to evaluate design changes, improve product robustness, and support verification and validation activities.
• Conduct hands-on product evaluations and laboratory investigations to validate engineering hypotheses.
• Lead risk management activities including hazard analysis, Failure Modes and Effects Analysis (FMEA), and risk documentation.
• Review engineering, supplier, and manufacturing changes to ensure compliance with quality and regulatory requirements.
• Analyze complaint and post-market data to identify emerging trends and drive product improvements.

What we're looking for

• Must possess a Bachelor's degree with 4+ years of relevant experience, a Master's degree with 2+ years of relevant experience, or a PhD.
• Must have experience in medical device, pharmaceutical, biotechnology, or other regulated product industries.
• Must possess unrestricted U.S. work authorization.
• Preferred: Experience with design controls, risk management, verification, validation, and engineering change processes.
• Preferred: Experience supporting embedded software, electronic hardware, circuit board-based, or electromechanical products.
• Preferred: Experience conducting root cause investigations and resolving product or process quality issues.
• Preferred: Experience applying statistical methods to product, reliability, quality, or process improvement activities.
• Preferred: Knowledge of ISO 13485, ISO 14971, IEC 60601, and European Union Medical Device Regulation (EU MDR).