Senior Reliability Engineer

What you'll do

• Analyze, debug, and recommend design or process changes to improve system and process reliability.
• Conduct risk analysis studies to identify how potential quality issues impact product quality or patient safety.
• Author technical reports, risk assessments, and documentation regarding analysis results or quality impacts.
• Support verification and validation of device system requirements, including traceability and testability.
• Evaluate finished product systems regarding requirements, design, development, integration, and validation.
• Interpret and decompose system requirements to verify compliance with applicable standards and specifications.
• Investigate quality issues with cross-functional partners to support corrective actions.
• Analyze product performance data to support post-market surveillance and product improvement activities.

What we're looking for

• Bachelor’s degree in Engineering, Science, or a technical discipline.
• 4+ years of related work experience or 2+ years of related work experience with an advanced degree.
• Unrestricted U.S. work authorization.
• Ability to evaluate and debug electrical designs, including RF performance (preferred).
• Experience with 21 CFR 820, ISO 13485, and ISO 14971 (preferred).
• Experience with design, verification, and validation of Class III medical devices or similar regulated products (preferred).
• Demonstrated ability to perform data analysis using statistical techniques and reliability tools (preferred).
• Experience in reliability engineering, risk management, or root cause investigations (preferred).