Job Title: Senior Reliability EngineerJob DescriptionThe Senior Reliability Engineer develops and executes reliability engineering programs that ensure products meet stringent performance, safety, and regulatory expectations. This role leads technical reliability studies, supports post-market activities, and drives continuous improvement across product design and processes, with a particular focus on ECLS products. The engineer works cross-functionally to analyze complex data, identify root causes, and recommend design or process changes that improve product reliability and customer satisfaction.
Responsibilities- Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts, including the design and execution of Design of Experiments (DOE).
- Recommend design or test methods and statistical process control procedures to achieve required levels of product reliability.
- Complete risk analysis studies for new designs and processes to ensure they meet internal, customer, and regulatory reliability objectives.
- Compile and analyze performance reports and process control statistics to identify and evaluate variables that may affect product and process performance.
- Ensure that corrective and preventive actions meet acceptable reliability standards and are effectively implemented.
- Analyze preliminary plans and develop reliability engineering programs that support company, customer, and governmental agency requirements.
- Develop mathematical models, when appropriate, to identify units, batches, or processes that present excessive failure risks.
- Propose changes in design, formulation, or processes to improve system and process reliability based on analytical findings.
- Determine units and batches that require environmental or other specialized testing and specify the minimum number of samples required to obtain statistically valid data.
- Lead and support complaint trending activities to identify patterns, emerging issues, and opportunities for improvement in ECLS products.
- Perform post-market change assessments to evaluate the reliability and quality impact of design, process, or manufacturing changes.
- Conduct issue investigations, including detailed root cause analysis, and drive resolution plans for post-market and quality-related problems.
- Collaborate closely with cross-functional teams, including engineering, quality, and other stakeholders, to align on reliability requirements and solutions.
- Prepare and deliver clear, concise technical reports and presentations for Senior internal and external stakeholders.
- Communicate effectively with internal and external customers and vendors to exchange technical information, status updates, and recommendations.
- Coach, guide, and mentor lower-level professionals, providing technical direction and feedback as needed.
- Manage and deliver projects from design through implementation, ensuring adherence to policies, procedures, and industry standards.
- Identify and implement process, system, or product improvements that enhance reliability performance and efficiency within the job area.
- Apply working knowledge of relevant industry standards, specification development, and geometric dimensioning and tolerancing (GD&T) to support design and testing activities.
- Balance multiple tasks and projects simultaneously, managing priorities and deadlines in a dynamic environment.
Essential Skills- Bachelor’s Degree in Engineering, Science, or a technical field with a minimum of 4 years of work experience in Engineering and/or Quality, or an advanced degree in Engineering, Science, or a technical field with a minimum of 2 years of relevant experience.
- Target of 2 to 7 years of experience in reliability engineering, quality engineering, or a closely related engineering discipline.
- Advanced knowledge of reliability engineering principles and practices, combining breadth and depth of expertise.
- Experience in medical device design and application of relevant test standards.
- Experience applying statistical methods to design reliability, process capability, and data analysis.
- Strong oral and written communication skills, including the ability to present complex information clearly.
- Demonstrated ability to manage time effectively and handle multiple tasks or projects concurrently.
- High level of attention to detail and accuracy in technical work and documentation.
- Proven ability to work cross-functionally and operate as an effective team player.
- Practical knowledge of project management, including planning, execution, and oversight of engineering or quality projects.
- Working knowledge o