Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems / procedures to optimize product development, internal and external device manufacturing, and device distribution.
Key Responsibilities :
Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles;
analyze results, make recommendations and develop reports.
Optimize moderately complex 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 basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Develop, update, and maintain technical content of risk management files
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Other incidental duties assigned by Leadership
Education and Experience :
Bachelor's Degree in in Engineering or Scientific field , 2 years min. years experience Required or
Master's Degree or equivalent in with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry / education Required
Additional Skills :
Good computer skills in usage of MS Office Suite; CAD experience preferred
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab / industrial equipment required
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Knowledge of and adherence to Quality systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
Ability to build productive internal / external working relationships
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence / control