The Sr. Quality Assurance Engineer works as part of the cross-functional product development team and focuses on planning and execution of product quality assurance tasks and testing. 

Responsibilities  

• Planning and execution of Product Quality Assurance tasks and testing with hands-on test development and qualification. 
• Material selection and qualification. 
• Collaboration with Product Development on POC and design assessments including biocompatibility assessment and testing as applicable. 
• Product specification validation; overseeing and conducting process validation. 
• Participation in Design Verification & Validation testing. 
• Review and editing of Engineering protocols and reports. 
• Performance of risk assessments, FMEA, and management activities. 
• Data collection and statistical analysis. 
• Writing protocols and reports. 
• Other duties as assigned by manager.  

Qualifications 

• Medical Device Design and Development Processes. 
• 3 to 5 to years’ experience working as a Product Quality Engineer. 
• Success working as part of a cross-functional team member. 
• Electro-Mechanical Device Development and Testing. 
• BS in Engineering and/or related science. 
• Experience and knowledge of Quality Management Systems. (QMS) 
• Knowledge of conducting statistical analysis. 
• Quality Assurance Applications – Design Control Knowledge. 
• Design Assurance Testing and Test Qualification. 
• Familiarity with Firmware and Software Program Validation. 
• Familiarity with Reliability Testing and Analysis. 
• Robotic medical device development experience. 
• Quality Engineer Certification. 
• Lean/Six Sigma Training and/or Certification. 
• Robotics and Systems Engineering. 
• Minitab or other statistical program experience. 
• Design Tolerance Analysis and methods. 
• Solid Works / CAD expertise. 
• Calibration training and expertise. 
• Some level of experience with Firmware and Software Program Validation. 
• Some level of experience conducting Reliability Testing and Analysis.