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. The QE will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.

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
• Identify opportunities for design and/or manufacturing transformation in a manner that ensures product development continues to evolve and improve
• Assist with developing technical content of risk management files
• Assist with developing training and documentation materials for production (e.g., inspection documents) to enable the seamless knowledge transfer of project and manufacturing processes from NPD to Operations

Required Qualifications:

• Bachelors or Masters degree in Engineering or Scientific field

Preferred Qualifications:

• Engineering degree
• Engineering/Internship experience within a medical device industry or highly regulated environment
• Quality Engineering experience in New Product Development.
• Experience providing support for either Design Assurance, Design Controls, Verification & Validation, and/or Test Method Development
• Class III new product development experience
• Knowledge of and experience with Risk Management (i.e. dFMEAs and/or pFMEAs), and reviewing or updating risk management documents.
• Knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)