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.
