Key Responsibilities:
•    Utilizing Quality Engineering tools/processes in the development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. 
•    Leading efforts for continuous quality and customer satisfaction improvement opportunities. 
•    Support the Non-Conformance Report (NCR) process for facilities located in the U.S. 
•    Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA. 
•    Write, review and/or approve process and product validation protocols and reports, equipment qualifications, and engineering change orders. 
•    Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC)
•    Design of Experiments (DOE), etc.
•    Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR is met per the MDR, and product is properly transferred to manufacturing per applicable specifications. 
•    Technical problem-solving, failure analysis, and root cause determination. 
•    Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work. 
•    Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment. 
•    Assigns/reviews quality inspection testing and test data. 
•    Keeps department supervisor abreast of activities and issues of the quality group.
•    Responsible for communicating business-related issues or opportunities to next management level
•    Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures 
•    Performs other duties assigned as needed 
•    Maintaining blank time records with necessary information on all contracts for business partners to use.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES
•    Bachelor’s degree, required; preferably in engineering and/or scientific discipline 
•    4-5 years of design quality engineering experience.
•    Catheter experience or class 3 delivery preferred
•    Experience in design transfer – DBT (testing of finished devices)
•    Process/equipment investigations
•    CAPA experience a plus
•    Manufacturing, or research and development experience in medical devices
•    Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
•    Ability to develop and implement Quality standards
•    Demonstrated auditing and problem-solving skills
•    Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies 
•    Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization. 
•    Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA is a plus. 
•    Working knowledge of SolidWorks, other CAD-based programs (ie. basic dimensioning, tolerance stack analysis) is a plus. 
•    Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools is a plus. 
•    Knowledge of Quality and operations systems and processes, including GMP is a plus.