Reliability Engineer and Lab Coordinator

Siemens Healthineers in Walpole, MA (onsite) invites you to join as a Reliability Engineer and Lab Coordinator. This role blends reliability modeling, testing, post-launch monitoring, and lab coordination for blood gas IVD point-of-care devices. You will influence design, manufacturing, and field performance through DFMEA and cross-functional reliability activities. The position offers a competitive salary range of USD 95,770 to 131,681 per year and a comprehensive benefits package that supports health, finances, and work-life balance.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term disability insurance
• Short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time

Responsibilities

• Own the overall reliability modeling, testing, and post-launch monitoring for our products.
• Develop a deep understanding of Siemens Healthineers blood gas IVD point-of-care devices from design through manufacturing and field performance.
• Apply design for reliability principles to support product testing procedures and field performance studies.
• Maintain Reliability Lab equipment and environment to ensure readiness for testing.
• Partner with R&D, quality assurance, and manufacturing to establish reliability requirements, cascade them, and create comprehensive reliability test plans aligned with development and production processes.
• Develop reliability plans and requirements, lead and facilitate DFMEA sessions.
• Design and develop test methods and fixtures to assess performance and durability of IVD devices.
• Write test protocols, train personnel on procedures, analyze data, and generate final reports.
• Conduct reliability tests including environmental, lifecycle, and accelerated aging tests, ensuring compliance with regulatory standards.
• Analyze test results, produce detailed reports, and identify areas for improvement and potential risks.
• Lead and direct multiple projects in a fast-paced, cross-functional environment.
• Participate in design reviews and drive Design for Reliability processes and tools to support reliability planning.
• Review device failures, perform root cause investigations, and document results in FRACAS.
• Compile and analyze performance and process-control statistics, investigating variables that may affect products and processes.
• Coordinate activities and equipment within the Reliability Lab.

Requirements

• Bachelor’s degree in Mechanical, Biomechanical, Reliability Engineering, or a related discipline; advanced degree preferred.
• 3+ years of reliability engineering experience in a highly regulated industry, preferably medical devices; 1+ year with a master’s degree.
• Experience planning tests, including design of experiments (DoE) and sample size selection.
• Proficiency with reliability and statistical analysis software such as Reliasoft, XFRACAS, and Minitab.

Technologies

• ReliaSoft
• XFRACAS
• Minitab