Role: Quality Engineer II

Location: Draper, UT - 84020

Duration: 6 Months

Job Description:

Position Summary:

The NPD Quality Engineer (QE) will provide support for several new transcatheter heart valve development projects focusing on risk management, test method development, and inspection methodologies.

This includes close coordination with manufacturing in the clean room for R&D builds as well as lab activities for design verification testing with R&D.

Key Responsibilities:

Apply knowledge of quality engineering principles and methods to ensure compliance with Quality System and also Regulatory requirements. Focus on design control, design verification/validation, FMEA, specification development, statistical reliability, critical to quality/process control, acceptance sampling, and inspection/test methodologies

Provide assistance to subject matter experts (SME) for responsible product/project within the overall manufacturing and processing of pericardial tissue heart valve assembly, including leveraging of key knowledge of quality engineering principles

Review design changes; partner with R&D in the design of safe and effective THV devices; partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality engineering support for pilot production of clinical devices

Optimize manufacturing processes using engineering methods (e.g., Six Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk

Develop basic experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion

Investigate basic manufacturing product quality and compliance issues (e.g. CAPA, NCR, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports