Reliability Engineer

SUMMARY:

This is a highly visible position located in our primary service center. The primary focus of this role is to own complaint investigation activities, including determining root causes for device quality issues and driving these issues to conclusion by interfacing with the Vapotherm R&D team and suppliers.

This role requires an onsite presence in Mesquite, TX, and includes a 10 to 15% travel requirement to troubleshoot quality issues directly with suppliers and Vapotherm’s Manufacturing and R&D facilities. Additionally, this position will provide support for maintaining calibrated devices and some incoming inspection activities.

• Conduct investigations of customer complaints to identify root causes and potential product or process issues.

• Partner with Vapotherm R&D and manufacturing teams to troubleshoot issues; collaborate with suppliers to drive them toward effective corrective actions.
• Provide input on process and design improvements to enhance product quality and reliability.

• Own complaint investigation processes to ensure reliable tracking. Prepare trend analysis reports, present findings to the company, and drive cross-functional Quality Data review meetings.
• Document investigation findings, corrective actions, and recommendations
• Conduct travel to Vapotherm R&D, Manufacturing Facilities, and suppliers to troubleshoot quality issues associated with complaints

• Oversee and maintain the service facilities calibration program to ensure all equipment is compliant and meets regulatory requirements.
• Coordinate with internal teams and external vendors to perform regular calibration of tools and equipment.

• Assist in limited incoming inspection activities for established supplier controls.
• Participate in risk assessments, including Failure Modes and Effects Analysis (FMEA).
• Support Engineering Change Orders (ECOs).
• Support internal and external audits and assist in maintaining QMS documentation and training.

• Bachelor’s degree in Engineering or a related field.
• 0-3 years of experience in the medical device, pharmaceutical, or regulated industry.

• Strong technical ability to understand the workings of devices, including mechanical parts and electronic components.
• Strong analytical and problem-solving skills.
• Proficiency in Microsoft Office Suite especially excel.
• Excellent verbal and written communication skills.

• Familiarity with root cause analysis methodologies.
• Hands-on experience with consumer hardware or medical device manufacturing or testing.

• Ability to work in a service/production environment.
• Occasionally required to lift and move objects weighing up to 25 pounds.